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"Laparotomy - methods"
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Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial
by
Lont, Harold E
,
Jeekel, Johannes
,
Cense, Huib A
in
Abdomen
,
Abdominal surgery
,
Abdominal Wound Closure Techniques - adverse effects
2015
Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity, decreased quality of life, and high costs. We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions.
We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned (1:1), via a computer-generated randomisation sequence, to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm. Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation. Patients and study investigators were masked to group allocation. The primary outcome was the occurrence of incisional hernia; we postulated a reduced incidence in the small bites group. We analysed patients by intention to treat. This trial is registered at Clinicaltrials.gov, number NCT01132209 and with the Nederlands Trial Register, number NTR2052.
Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=284) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) patients completed follow-up and were included in the primary outcome analysis. Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group (mean number of stitches 45 [SD 12] vs 25 [10]; p<0·0001), a higher ratio of suture length to wound length (5·0 [1·5] vs 4·3 [1·4]; p<0·0001) and a longer closure time (14 [6] vs 10 [4] min; p<0·0001). At 1 year follow-up, 57 (21%) of 277 patients in the large bites group and 35 (13%) of 268 patients in the small bites group had incisional hernia (p=0·0220, covariate adjusted odds ratio 0·52, 95% CI 0·31–0·87; p=0·0131). Rates of adverse events did not differ significantly between groups.
Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events. The small bites technique should become the standard closure technique for midline incisions.
Erasmus University Medical Center and Ethicon.
Journal Article
Effects of the short-stitch technique for midline abdominal closure: short-term results from the randomised-controlled ESTOIH trial
2022
PurposeThe short-stitch technique for midline laparotomy closure has been shown to reduce hernia rates, but long stitches remain the standard of care and the effect of the short-stitch technique on short-term results is not well known. The aim of this study was to compare the two techniques, using an ultra-long-term absorbable elastic suture material. MethodsFollowing elective midline laparotomy, 425 patients in 9 centres were randomised to receive wound closure using the short-stitch (USP 2-0 single thread, n = 215) or long-stitch (USP 1 double loop, n = 210) technique with a poly-4-hydroxybutyrate-based suture material (Monomax®). Here, we report short-term surgical outcomes. ResultsAt 30 (+10) days postoperatively, 3 (1.40%) of 215 patients in the short-stitch group and 10 (4.76%) of 210 patients in the long-stitch group had developed burst abdomen [OR 0.2830 (0.0768–1.0433), p = 0.0513]. Ruptured suture, seroma and hematoma and other wound healing disorders occurred in small numbers without differences between groups. In a planned Cox proportional hazard model for burst abdomen, the short-stitch group had a significantly lower risk [HR 0.1783 (0.0379–0.6617), p = 0.0115]. ConclusionsAlthough this trial revealed no significant difference in short-term results between the short-stitch and long-stitch techniques for closure of midline laparotomy, a trend towards a lower rate of burst abdomen in the short-stitch group suggests a possible advantage of the short-stitch technique.Trial registryNCT01965249, registered October 18, 2013.
Journal Article
The MESH-RTL Project for prevention of abdominal wound dehiscence (AWD) in high-risk patients: noninferiority, randomized controlled trial
2024
PurposeTo compare reinforced tension line (RTL) and mesh techniques in the onlay position for preventing abdominal wound dehiscence (AWD) in a noninferiority clinical trial.MethodsPatients > 18 years old who underwent midline laparotomy and who were considered at high risk on the modified Rotterdam risk scale were included. The outcomes analyzed were the incidence of AWD and surgical site occurrence (SSO).Results239 patients were included: 121 mesh group and 118 RTL group. Five (4.1%) of the 121 patients in the mesh group and 7 (5.9%) of the 118 patients in the RTL group presented with AWD (p = 0.56, RR = 0.69, 95% CI = 0.22–2.13) in the per-protocol analysis. The median time of presentation was 6 days. The 95% CI (−0.0567, 0.0231) for the difference in incidence between the two groups was entirely within the predefined noninferiority margin of 5%. The incidence of complications did not significantly differ between the two groups: the mesh group (27, 22.3%) and the RTL group (16, 12.8%) (p = 0.09, RR (95% CI) = 1.64 (0.93–2.89)).ConclusionThe use of the RTL technique for preventing AWD was not inferior to the use of mesh in the onlay position, nor did it increase the risk of complications. This study was registered on clinicaltrials.gov: Mesh-RTL Project (NCT04134455).
Journal Article
STAT trial: stoma or intestinal anastomosis for necrotizing enterocolitis: a multicentre randomized controlled trial
2024
PurposeThe STAT trial is a multicenter randomized controlled trial in 12 centers worldwide aiming to determine the most effective operation for neonates with necrotizing enterocolitis (NEC) requiring intestinal resection: stoma formation (ST) or primary anastomosis (PA).MethodsInfants having a primary laparotomy for NEC were randomized intraoperatively to PA or ST if the operating surgeon thought that both were viable treatment options for that patient. The primary outcome (duration of parenteral nutrition [PN]) was evaluated by Cox regression.ResultsEighty patients were recruited from 2010 to 2019. Infants undergoing anastomosis finished PN significantly earlier than patients undergoing stoma (hazard ratio PA vs. ST 2.38, 95% CI 1.36–4.12 p = 0.004). There was no difference in mortality between the two groups (PA 4/35 vs. ST 8/38 p = 0.35) or in the rate of complications requiring further unplanned operations (p = n.s.). Multiple intestinal complications were more frequent in the stoma group compared to the anastomosis group (ST 12/26 vs. PA 5/31, p = 0.02, Fisher’s Exact test).ConclusionAt laparotomy for NEC, when there is no disease distal to resected intestine, primary anastomosis should be performed as it enhances the recovery from NEC, reduces the risk of multiple intestinal complications and does not increase adverse outcomes.
Journal Article
The Analysis of Risk Factors in the Conversion from Laparoscopic to Open Cholecystectomy
by
Podlasek, Robert
,
Łuszczki, Edyta
,
Oleksy, Łukasz
in
Abdomen
,
Cardiovascular disease
,
Cholecystectomy
2020
Laparoscopic cholecystectomy is a standard treatment for cholelithiasis. In situations where laparoscopic cholecystectomy is dangerous, a surgeon may be forced to change from laparoscopy to an open procedure. Data from the literature shows that 2 to 15% of laparoscopic cholecystectomies are converted to open surgery during surgery for various reasons. The aim of this study was to identify the risk factors for the conversion of laparoscopic cholecystectomy to open surgery. A retrospective analysis of medical records and operation protocols was performed. The study group consisted of 263 patients who were converted into open surgery during laparoscopic surgery, and 264 randomly selected patients in the control group. Conversion risk factors were assessed using logistic regression analysis that modeled the probability of a certain event as a function of independent factors. Statistically significant factors in the regression model with all explanatory variables were age, emergency treatment, acute cholecystitis, peritoneal adhesions, chronic cholecystitis, and inflammatory infiltration. The use of predictive risk assessments or nomograms can be the most helpful tool for risk stratification in a clinical scenario. With such predictive tools, clinicians can optimize care based on the known risk factors for the conversion, and patients can be better informed about the risks of their surgery.
Journal Article
Prophylactic PICO◊ dressing shortens wound dressing requirements post emergency laparotomy (EL-PICO◊ trial)
2024
Background
Surgical site infection (SSI) is a very common complication of emergency laparotomy and causes significant morbidity. The PICO
◊
device delivers negative pressure wound therapy (NPWT) to closed incisions, with some studies suggesting a role for prevention of SSI in heterogenous surgical populations. We aimed to compare SSI rates between patients receiving PICO
◊
versus conventional dressing post-emergency laparotomy. Secondary objectives were to observe seroma and dehiscence rates, length of stay, days on dressing and patients’ wound experience.
Methods
This double blinded randomized controlled trial was conducted in University Malaya Medical Centre between October 2019 and March 2022. Patients undergoing emergency laparotomy requiring incisions less than 35 cm were included. Statistical analysis was performed using χ
2
test for categorical variables, independent T-test or Mann–Whitney U were used for parametric or non-parametric data respectively besides logistic regression.
P
values of < 0.05 were considered to be significant.
Results
Ninety-six patients were analyzed (47 interventions, 49 controls). The duration on dressing was more consistent in the intervention arm (PICO
◊
) versus control arm [9.78 ± 10.20 vs 17.78 ± 16.46 days,
P
< 0.001]. There was a trend towards lower SSI [14.3 vs 4.3%,
P
= 0.09], dehiscence [27.1 vs 10.6%,
P
= 0.07] and seroma [40.8 vs 23.4%,
P
= 0.08] rates in the intervention arm but this did not reach statistical significance. Length of stay [9 (IQR: 6–14) vs 11 (IQR: 6–22.5) days,
P
= 0.18] was fairly similar between the two arms, but more patients were very satisfied with PICO
◊
compared to the conventional dressing [80% vs 57.1%,
P
= 0.03].
Conclusion
The use of NPWT in emergency laparotomy improves patients wound care experience, and was associated with trends towards fewer wound related complications. Cost effectiveness needs to be explored in order to further validate its use in the emergency setting, especially for patients with additional risk for SSI.
Trial registration
National Medical Research Registry (NMRR): NMRR-20-1975-55222.
Journal Article
Brief Pain Inventory (BPI) Health Survey After Midline Laparotomy With the Rectus Sheath Block (RSB) Analgesia: A Randomised Trial of Patients With Cancer and Benign Disease
by
RAHKOLA, DINA
,
KOKKI, HANNU
,
ESKELINEN, MATTI
in
Activities of Daily Living
,
Analgesia
,
Cancer
2019
Our original hypothesis was that the rectus sheath block (RSB) analgesia could enhance patient satisfaction and decrease pain following midline laparotomy.
Initially, 56 patients were randomized into four groups; control group (n=12), single-dose (n=16), repeated-dose (n=12) and continuous infusion (n=16) RSB analgesia groups. The BPI (Brief Pain Inventory) survey was conducted preoperatively and at one and four weeks and 12 months postoperatively. The patients pain 24 h postoperatively and satisfaction 48 h postoperatively was filled on an 11-point numeric rating scale (NRS).
The repeated-dose group had lower BPI severity score (p=0.045) and BPI interference score (p=0.043) mean values postoperatively compared to the three other groups separately. Also, the time effect on the linear mixed model in BPI interference score mean values was statistically significant (p=0.008), which means that in the repeated dose group preoperative BPI severity score [2.7 (3.9)] and interference score [4.3 (4.2)] mean (SD) values were significantly higher than the BPI severity score [1.3 (0.8)] and interference score [1.5 (1.8)] mean (SD) values following surgery.
The higher elevation in BPI severity score and decrease in interference score values in the repeated dose group and also the time effect in a linear mixed model in BPI interference score were statistically significant.
Journal Article
The 6:1 short stitch SL-WL-ratio: short term closure results of transverse and midline incisions in elective and emergency operations
by
Zielska, Z.
,
Baumann, P.
,
Golling, M.
in
Abdomen
,
Abdominal Muscles - surgery
,
Abdominal Surgery
2024
Aim
To analyze laparotomy closure quality (suture/wound length ratio; SL/WL) and short term complications (surgical site occurrence; SSO) of conventional midline and transverse abdominal incisions in elective and emergency laparotomies with a longterm, absorbent, elastic suture material.
Method
Prospective, monocentric, non-randomized, controlled cohort study on short stitches with a longterm resorbable, elastic suture (poly-4-hydroxybutyrate, [p-4OHB]) aiming at a 6:1 SL/WL-ratio in midline and transverse, primary and secondary laparotomies for elective and emergency surgeries.
Results
We included 351 patients (♂: 208; ♀: 143) with midline (
n
= 194), transverse (
n
= 103), and a combined midline/transverse L-shaped (
n
= 54) incisions. There was no quality difference in short stitches between elective (
n
= 296) and emergency (
n
= 55) operations. Average SL/WL-ratio was significantly higher for midline than transverse incisions (6.62 ± 2.5 vs 4.3 ± 1.51,
p
< 0.001). Results in the first 150 patients showed a reduced SL/WL-ratio to the following 200 suture closures (SL/WL-ratio: 5.64 ± 2.5 vs 6.1 ± 2.3;
p
< 0.001). SL/WL-ratio varied insignificantly among the six surgeons participating while results were steadily improving over time.
Clinically, superficial surgical site infections (SSI, CDC-A1/2) were encountered in 8%, while 4,3% were related to intraabdominal complications (CDC-A3). An abdominal wall dehiscence (AWD) occurred in 22/351 patients (6,3%)—twice as common in emergency than elective surgery (12,7 vs 5,1%)—necessitating an abdominal revision in 86,3% of cases.
Conclusion
We could show that a short stitch 6:1 SL/WL-ratio with a 2–0 single, ultra-long term, absorbent, elastic suture material can be performed in only 43% of cases (85% > 4:1 SL/WL-ratio), significantly better in midline than transverse incisions. Transverse incisions should preferably be closed in two layers to achieve a sufficient SL/WL-ratio equivalent to the median incision.
Clinical Trials.gov Identifier
NCT01938222.
Journal Article
Laparoscopy versus open distal gastrectomy by expert surgeons for early gastric cancer in Japanese patients: short-term clinical outcomes of a randomized clinical trial
by
Katada, Natsuya
,
Futawatari, Nobue
,
Yamashita, Keishi
in
Abdominal Surgery
,
Administration, Rectal
,
Aged
2013
Background
Short-term outcomes of laparoscopy-assisted distal gastrectomy (LADG) and open DG (ODG) have been investigated in previous clinical trials, but operative techniques and concomitant treatments have evolved, and up-to-date evidence produced by expert surgeons is required to provide an accurate image of the relative efficacies of the treatments. The purpose of this study was to compare laparoscopic versus ODG with respect to specific primary and secondary short-term outcomes.
Methods
From October 2005 to February 2008, a total of 64 patients with early gastric cancer were randomly assigned to the LADG or the ODG group. One patient was excluded due to concurrent illness unrelated to the intervention, so the data from 63 patients were analyzed. The primary short-term outcome was the 4-day postoperative use of analgesics. Secondary short-term outcomes were postoperative residual pain, complications, days hospitalized, blood data, days with fever, and days to first flatus.
Results
There was a significant difference in favor of LADG for postoperative use of analgesics (
P
= 0.022). Unexpectedly, there was no significant difference in degree of pain in the immediate postoperative period, putatively due to the optimal use of analgesics. Of the secondary outcomes, residual pain at postoperative day 7 (
P
= 0.003) and days to first flatus (
P
= 0.001) were significantly better with LADG. Postoperative complications, number of days hospitalized, and number of days with fever were also better with LADG, but the differences were not significant. Blood data representing inflammation (WBC and CRP) showed marked differences, especially on postoperative day 7 (
P
= 0.0016 and
P
= 0.0061, respectively).
Conclusions
LADG performed by expert surgeons results in less postoperative pain accompanied by decreased surgical invasiveness and is associated with fewer postoperative inconveniences. No preliminary suggestions of changes in long-term curability were observed. LADG for early gastric cancer is a feasible and safe procedure with short-term clinical results superior to those of ODG.
Journal Article
Mini-laparotomy versus transrectal natural orifice specimen extraction for minimally invasive colorectal cancer surgery: study protocol for a randomized controlled trial (MINITR-NOSE trial, TCAR2514 protocol)
2025
Background
Minimally invasive surgery (MIS) has improved colorectal cancer (CRC) treatment by reducing recovery time, pain, and infection risk compared to traditional open surgery, though a mini laparotomy is still needed for specimen removal. Natural orifice specimen extraction (NOSE) offers a promising alternative by using natural body openings for extraction, potentially minimizing complications further, yet requires more evidence to confirm its safety and effectiveness over conventional methods.
Methods
This single-center randomized controlled trial at Linkou Chang-Gung Memorial Hospital includes CRC patients meeting specific eligibility criteria, randomly assigned to undergo either NOSE or conventional MIS. Primary outcomes focus on postoperative C-reactive protein (CRP) levels as a marker of inflammation, with secondary outcomes evaluating short-term complications, recovery, readmission, and long-term survival. Both groups will receive routine perioperative care following modified Enhanced Recovery After Surgery (ERAS) protocols, with postoperative pain and complications systematically recorded and graded.
Discussion
This study seeks to determine whether the NOSE approach offers advantages over conventional MIS by reducing inflammation and complications, potentially improving patient recovery and outcomes. If effective, NOSE may present a less invasive alternative for CRC resection, contributing to advancements in colorectal surgical oncology.
Trial registration
ClinicalTrials.gov NCT05740267. Registered on March 1, 2023.
Journal Article