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"Appendectomy - adverse effects"
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Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial
2023
Appendicectomy remains the standard treatment for appendicitis. No international consensus exists on the surgical urgency for acute uncomplicated appendicitis, and recommendations vary from surgery without delay to surgery within 24 h. Longer in-hospital delay has been thought to increase the risk of perforation and further morbidity. Therefore, we aimed to compare the rate of appendiceal perforation in patients undergoing appendicectomy scheduled to two different urgencies (<8 h vs <24 h).
In this pragmatic, open-label, multicentre, non-inferiority, parallel, randomised controlled trial in two hospitals in Finland and one in Norway, patients (aged ≥18 years) with presumed uncomplicated acute appendicitis were randomly assigned (1:1) to an appendicectomy scheduled within 8 h or within 24 h to determine whether longer in-hospital delay (time between randomisation and surgical incision) is not inferior to shorter delay. Patients were excluded in cases of pregnancy, suspicion of perforated appendicitis (C-reactive protein level of ≥100 mg/L, fever >38·5°C, signs of complicated appendicitis on imaging studies, or clinical generalised peritonitis), or other reasons requiring prompt surgery. The recruiters were on-duty surgeons who decided to proceed with the appendicectomy. The randomisation sequence was generated using block randomisation with randomly varying block sizes and stratified by hospital districts; neither physicians nor patients were masked to group assignment. The primary outcome was perforated appendicitis diagnosed during surgery analysed in all patients who received an appendicectomy by intention to treat. The absolute difference in rates of perforated appendicitis was compared between the groups. Complications and other safety outcomes were analysed in all patients who received an appendicectomy. A margin of 5 percentage points was used to establish non-inferiority. This trial was registered at ClinicalTrials.gov (NCT04378868) and is closed to accrual.
Between May 18, 2020, and Dec 31, 2022, 2095 patients were assessed for eligibility, of whom 1822 were randomly assigned to appendicectomy scheduled within 8 h (n=914) or 24 h (n=908). After randomisation, 19 (1%) of 1822 patients were excluded due to protocol violation. 1803 patients were included in the intention-to-treat analyses, 985 (55%) of whom were male and 818 (45%) female. Appendiceal perforation rate was similar between groups (77 [8%] of 907 patients assigned to the <8 h group and 81 [9%] of 896 patients assigned to the <24 h group; absolute risk difference 0·6% [95% CI –2·1 to 3·2], p=0·68; risk ratio 1·065, 95% CI 0·790 to 1·435). No significant difference was found between the complication rates within 30 days (66 [7%] of 907 patients in the <8 h group vs 56 [6%] of 896 patients in the <24 h group; difference –1·0% [–3·3 to 1·3]; p=0·39), and no deaths occurred during this follow-up period.
In patients with presumed uncomplicated acute appendicitis, scheduling appendicectomy within 24 h does not increase the risk of appendiceal perforation compared with scheduling appendicectomy within 8 h. The results can be used to allocate operating room resources, for example postponing night-time appendicectomy to daytime.
The Finnish Medical Foundation, Mary and Georg Ehrnrooth's Foundation, Biomedicum Helsinki Foundation, and the Finnish Government.
Journal Article
SAME day amBulatory c (SAMBA): a multicenter, prospective, randomized clinical trial protocol
2024
A recent meta-analysis concluded that outpatient appendectomy appears feasible and safe, but there is a lack of high-quality evidence and a randomized trial is needed. The aim of this trial is to demonstrate that outpatient appendectomy is non-inferior to conventional inpatient appendectomy in terms of overall morbi-mortality on the 30th postoperative day (D30).
SAMBA is a prospective, randomized, controlled, multicenter non-inferiority trial. We will include 1400 patients admitted to 15 French hospitals between January 2023 and June 2025. Inclusion criteria are patients aged between 15 and 74 years presenting acute uncomplicated appendicitis suitable to be operated by laparoscopy. Patients will be randomized to receive outpatient care (day-surgery) or conventional inpatient care with overnight hospitalization in the surgery department. The primary outcome is postoperative morbi-mortality at D30. Secondary outcomes include time from diagnosis to appendectomy, length of total hospital stay, re-hospitalization, interventional radiology, re-interventions until D30, conversion from outpatient to inpatient, and quality of life and patient satisfaction using validated questionnaires.
The SAMBA trial tests the hypothesis that outpatient surgery (i.e., without an overnight hospital stay) of uncomplicated acute appendicitis is a feasible and reliable procedure in establishments with a technical platform able to support this management strategy.
ClinicalTrials.gov NCT05691348. Registered on 20 January 2023.
Journal Article
Endoscopic retrograde appendicitis therapy versus laparoscopic appendectomy versus open appendectomy for acute appendicitis: a pilot study
2022
Background
An increasing number of studies have shown the merits of endoscopic retrograde appendicitis therapy (ERAT) in diagnosing and treating acute uncomplicated appendicitis. However, no related prospective controlled studies have been reported yet. Our aim is to assess the feasibility and safety of ERAT in the treatment of acute uncomplicated appendicitis.
Methods
In this open-label, randomized trial, participants were randomly allocated to the ERAT group, laparoscopic appendectomy (LA) group and open appendectomy (OA) group. The primary outcome was the clinical success rate of the treatment. Intention-to-treat analysis was used in the study.
Results
The study comprised of 99 patients, with 33 participants in each group. The clinical success rate was 87.88% (29/33), 96.97% (32/33) and 100% (33/33) in the ERAT, LA and OA group, respectively. In the ERAT group, 4 patients failed ERAT due to difficult cannulation. In LA group, 1 patient failed because of abdominal adhesion. There were no significant differences among the three treatment groups regarding the clinical success rate (
P
= 0.123). The median duration of follow-up was 22 months. There were no significant differences (
P
= 0.693) among the three groups in terms of adverse events and the final crossover rate of ERAT to surgery was 21.21% (7/33).
Conclusion
ERAT can serve as an alternative and efficient method to treat acute uncomplicated appendicitis.
Trial registration
The study is registered with the WHO Primary Registry-Chinese Clinical Trial Registry (ChiCTR1900025812).
Journal Article
Delayed versus primary closure to minimize risk of surgical-site infection for complicated appendicitis: A secondary analysis of a randomized trial using counterfactual prediction modeling
2024
To evaluate the risk of surgical site infection (SSI) following complicated appendectomy in individual patients receiving delayed primary closure (DPC) versus primary closure (PC) after adjustment for individual risk factors.
Secondary analysis of randomized controlled trial (RCT) with prediction model.
Referral centers across Thailand.
Adult patients who underwent appendectomy via a lower-right-quadrant abdominal incision due to complicated appendicitis.
A secondary analysis of a published RCT was performed applying a counterfactual prediction model considering interventions (PC vs DPC) and other significant predictors. A multivariable logistic regression was applied, and a likelihood-ratio test was used to select significant predictors to retain in a final model. Factual versus counterfactual SSI risks for individual patients along with individual treatment effect (iTE) were estimated.
In total, 546 patients (271 PC vs 275 DPC) were included in the analysis. The individualized prediction model consisted of allocated intervention, diabetes, type of complicated appendicitis, fecal contamination, and incision length. The iTE varied between 0.4% and 7% for PC compared to DPC; ∼38.1% of patients would have ≥2.1% lower SSI risk following PC compared to DPC. The greatest risk reduction was identified in diabetes with ruptured appendicitis, fecal contamination, and incision length of 10 cm, where SSI risks were 47.1% and 54.1% for PC and DPC, respectively.
In this secondary analysis, we found that most patients benefited from early PC versus DPC. Findings may be used to inform SSI prevention strategies for patients with complicated appendicitis.
Journal Article
Postoperative recovery in peroral versus intravenous antibiotic treatment following laparoscopic appendectomy for complicated appendicitis: a substudy of a cluster randomized cluster crossover non-inferiority study
by
Zeyghami, Walid
,
Gögenur, Ismail
,
Mohamud, Ahmed Abdirahman
in
Abdominal Surgery
,
Abscesses
,
Administration, Intravenous
2024
Background
Acute appendicitis is the most common cause of abdominal pain requiring surgery, usually managed with laparoscopic appendectomy. In Denmark, the standard postoperative treatment for complicated cases involves intravenous antibiotics. This study compares peroral versus intravenous antibiotics in the context of fast-track surgery and Enhanced Recovery After Surgery (ERAS) protocols. Our objective is to evaluate the impact of peroral versus intravenous antibiotics on patient-reported outcomes following laparoscopic appendectomy for complicated appendicitis.
Methods
This was a sub-study within a broader Danish cluster-randomized non-inferiority trial conducted at Zealand University Hospital, focusing on adult patients undergoing laparoscopic appendectomy for complicated appendicitis. Participants were randomized into two groups: one receiving a three-day course of peroral antibiotics and the other intravenous antibiotics after surgery. Recovery quality was assessed on the third postoperative day using the Quality of Recovery-15 (QoR-15) questionnaire.
Results
The study included 54 patients, 23 in the peroral and 31 in the intravenous groups. The peroral group reported significantly better recovery outcomes, with higher QoR-15 scores (mean difference of 12 points,
p
< 0.001). They also experienced shorter hospital stays, averaging 47 h less than the intravenous group (
p
< 0.001). No significant differences between the groups were observed in readmissions or severe postoperative complications.
Conclusions
Peroral antibiotic administration after laparoscopic appendectomy for complicated appendicitis significantly improves patient recovery and reduces hospital stay compared to intravenous antibiotics. These results advocate a potential shift towards peroral antibiotic use in postoperative care, aligning with ERAS principles.
Trial Registration Number
ClinicalTrials.gov NCT04803422.
Journal Article
Appendectomy versus Antibiotic Treatment in Acute Appendicitis. A Prospective Multicenter Randomized Controlled Trial
2006
Background Appendectomy has been the treatment for acute appendicitis for over 120 years. Antibiotic treatment has occasionally been used in small uncontrolled studies, instead of operation, but this alternative has never before been tried in a multicenter randomized trial. Patients and Methods Male patients, 18–50 years of age, admitted to six different hospitals in Sweden between 1996 and 1999 were enrolled in the study. No women were enrolled by decision of the local ethics committee. If appendectomy was planned, patients were asked to participate, and those who agreed were randomized either to surgery or to antibiotic therapy. Patients randomized to surgery were operated on with open surgery or laparoscopically. Those randomized to antibiotic therapy were treated intravenously for 2 days, followed by oral treatment for 10 days. If symptoms did not resolve within 24 hours, an appendectomy was performed. Participants were monitored at the end of 1 week, 6 weeks, and 1 year. Results During the study period 252 men participated, 124 in the surgery group and 128 in the antibiotic group. The frequency of appendicitis was 97% in the surgery group and 5% had a perforated appendix. The complication rate was 14% in the surgery group. In the antibiotic group 86% improved without surgery; 18 patients were operated on within 24 hours, and the diagnosis of acute appendicitis was confirmed in all but one patient, and he was suffering from terminal ileitis. There were seven patients (5%) with a perforated appendix in this group. The rate of recurrence of symptoms of appendicitis among the 111 patients treated with antibiotics was 14% during the 1‐year follow‐up. Conclusions Acute nonperforated appendicitis can be treated successfully with antibiotics. However, there is a risk of recurrence in cases of acute appendicitis, and this risk should be compared with the risk of complications after appendectomy.
Journal Article
Laparoscopic versus open appendectomy: a prospective randomized comparison
2010
Background
Whether laparoscopy offers a benefit over open surgery in the management of acute appendicitis or not remains a subject of controversy despite the publication of numerous randomized studies. This study aimed to compare laparoscopic appendectomy (LA) with open appendectomy (OA) and to ascertain its therapeutic benefit.
Methods
Adult patients older than 14 years presenting with signs and symptoms suggestive of acute appendicitis were randomized to undergo either LA or OA from January 2006 to December 2007. Comparisons were based on operating time, time until return to a general diet, time until return to normal activity and work, length of hospital stay, billed charges, and postoperative complications.
Results
The study enrolled 220 patients: 108 to undergo OA and 112 to undergo LA. The groups were similar in terms of clinicopathologic characteristics. The operating time seemed to be shorter for the OA patients than for the LA patients, but the difference was not significant (LA, 30 ± 15.2 min vs. OA, 28.7 ± 16.3 min;
p
> 0.05). The hospital stay of 4.1 ± 1.5 days for the LA group and 7.2 ± 1.7 days for the OA group, and the difference was statistically significant (
p
< 0.05). Laparoscopic appendectomy remained associated with a shorter time until return to a general diet (LA, 20.2 ± 12.4 h vs. OA, 36.5 ± 10 h;
p
< 0.05), to normal activity (LA, 9.1 ± 4.2 days vs. OA, 13.7 ± 5.8 days;
p
< 0.05), and to work (LA, 21.2 ± 3.5 days vs. OA, 27.7 ± 4.9 days;
p
< 0.05). The billed charges appeared to be higher for LA (LA, 5,720.3 ± 115.7 yuan vs. OA, 5,310 ± 575.4 yuan), but this difference failed to be clinically important or statistically significant (
p
> 0.05). Wound infections were more common after OA (
n
= 14) than after LA (
n
= 0) (
p
< 0.05). Intraabdominal abscesses occurred for two patients in the LA group and nine patients in the OA group (
p
< 0.05). Postoperative ileus occurred with frequencies of 0% in the LA group and 7.4% in the OA group (
p
< 0.05). The rate for overall complications was significantly lower in the LA group.
Conclusion
Laparoscopic appendectomy is a useful tool in the treatment of acute appendicitis. Its advantages lie in its minimal invasiveness, its better cosmetic outcome, its lower rate of complications based on surgical expertise and state-of-the-art equipment. It can be recommended as an adoptable method for the routine patient with appendicitis.
Journal Article
Role of intraoperative antibiotics wound irrigation in reducing surgical site infection following open appendectomy: a randomized controlled trial
by
Jumaah, Mohammed Dhari
,
Shuhata, Mahmood Hasen
,
Al-Ani, Ibrahim Issam
in
Abdomen
,
Adolescent
,
Adult
2025
Background
Surgical site infection (SSI) is a common complication following open appendectomy, particularly in low and middle income countries. Intraoperative wound irrigation with antibiotic solutions has been used as a preventive strategy, though its efficacy remains debated.
Objective
To evaluate the effectiveness of intraoperative wound irrigation using a combination of ceftriaxone and metronidazole in reducing SSIs after open appendectomy, compared to normal saline irrigation.
Methods
A double-blind randomized controlled trial was conducted between July 2023 and December 2024 at Abu Ghraib General Hospital. A total of 410 patients aged 15–50 years with acute appendicitis undergoing open appendectomy were randomized into two groups. The experimental group received layer by layer irrigation with ceftriaxone and metronidazole, while the control group received saline irrigation. Postoperative follow-up was conducted on days 10, 15, and 30 to assess the incidence of SSIs using CDC criteria.
Results
There was no statistically significant difference in SSI rates between the experimental and control groups (4.1% vs. 6.6%;
p
= 0.278). Among patients with perforated appendices, SSI rates remained statistically insignificant between the two groups. Preoperative CRP and WBC levels were significantly higher in patients who developed SSIs (
p
< 0.0001). No significant difference was observed in hospital stay duration between the groups.
Conclusion
Intraoperative wound irrigation with ceftriaxone and metronidazole did not significantly reduce SSI incidence compared to saline irrigation in open appendectomy. Routine use of antibiotic irrigation may not be justified.
Trial registration
: The study was retrospectively registered with the International Standard Randomised Controlled Trial Number (ISRCTN) registry under the registration number ISRCTN19878512 on 19 May 2025.
Journal Article
Effect of Ondansetron on Postoperative Pain and Vomiting after Acute Appendicitis Surgery: A Placebo‐Controlled Double‐Blinded Randomized Clinical Trial
2024
Background . Common postoperative complications following surgery, particularly acute appendicitis surgery, include postoperative pain and vomiting, which can cause discomfort and delay recovery time. Methods . A randomized double‐blinded placebo‐controlled clinical trial was conducted with 80 cases of acute appendicitis of American Society of Anesthesiologists (ASA) physical status I or II and aged 18–60 y/o scheduled for appendectomy under general anesthesia. Patients were randomly divided into two equal groups: group A received 4 mg of ondansetron IV (2 ml) and group B received 2 ml of normal slain IV (placebo). Pain according to VAS, nausea and vomiting according to clinical symptoms, shivering and sedation according to the Bedside Shivering Assessment Scale (BSAS), and the Ramsay Sedation Scale (RSS) at 2, 6, 12, and 24 hours after surgery were evaluated and compared between the groups. Results . There was a significant decline in the severity of pain only at 2 hours after surgery between the ondansetron and control groups (5.3 ± 1.0 vs. 6.0 ± 1.0; p = 0.01), not showing a difference between the groups at 6, 12, and 24 hours after appendectomy. Postoperative nausea and vomiting at 2 (5% vs. 25%; p = 0.03) and 6 (7.5% vs. 27.5%; p = 0.04) hours after appendectomy in the ondansetron group. At different times, the ondansetron and control groups did not differ in terms of pethidine consumption or sedation. Conclusions . In conclusion, our study found that ondansetron was effective in reducing postoperative vomiting after acute appendicitis surgery. However, it did not show a clinically significant effect on postoperative pain. This trial is registered with IRCT20230722058883N1 .
Journal Article
Clinical recovery in children with uncomplicated appendicitis undergoing non-operative treatment: secondary analysis of a prospective cohort study
by
Bakx, Roel
,
Gorter, Ramon R
,
Johanna H van der Lee
in
Appendectomy
,
Appendicitis
,
C-reactive protein
2019
Non-operative treatment of uncomplicated appendicitis in children is gaining ground. Pending definitive evidence regarding its effectiveness, there is a call to evaluate clinical recovery after non-operative treatment. In this study, we analyzed data collected during initial admission of a multicenter prospective cohort in which children, 7–17 year, were treated non-operatively for uncomplicated appendicitis. During admission clinical parameters (pain and gastro-intestinal symptoms), inflammation parameters and sequential abdominal ultrasound were recorded. In total, 45 children were included, 42(93%) were discharged without the need for appendectomy; median [IQR] pain scores on admission were 5 [4–7], decreasing to 2 [0–3] after 1 day of treatment. Initially, 28/42 (67%) reported nausea and 19/42 (45%) vomiting; after 1 day, this was 3/42 (7%) and 1/42 (2%), respectively. White blood cell count declined from a median [IQR] of 12.9 [10.7–16.7] 10E9/L on admission to 7.0 [5.8–9.9] 10E9/L on day 1. Median [IQR] C-reactive protein levels increased from 27.5 [9–69] mg/L on admission to 48 [22–80] mg/L on day 1, declining to 21.5 [11–42] mg/L on day 2. Follow-up ultrasound showed no signs of complicated appendicitis in any of the patients.Conclusion: Clinical symptoms resolved in most children after 1 day of non-operative treatment. This suggests that non-operative treatment is a viable alternative to appendectomy regarding clinical recovery.Trail registration: NCT01356641What is Known:• Non-operative treatment of uncomplicated appendicitis in children is safe and its use around the world is gaining ground, however high quality evidence from adequately designed randomized trials is still lacking.• Concerns have been raised regarding the potentially prolonged clinical recovery associated with non-operative treatment.What is New:• Most clinical symptoms resolve after 1 day of non-operative treatment in the majority of children.
Journal Article