Suture Techniques for Preventing Incisional Hernia After Liver Surgery
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Abdominal hernia, Mesh placement, Pregnancy
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver tumor surgery. This study may help researchers learn if one technique can lower the chances of developing a hole in the wall of the abdomen (an abdominal hernia) at the incision site better than the other.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Short Stitch Suture, Short Stitch Technique, Small Bites Suture, Short Stitch Suture, Traditional Suture, Long Stitch Suture, Traditional Closure Technique for preventing incisional hernia after liver surgery?
Research shows that using small stitches and short stitch intervals can reduce the risk of incisional hernia and surgical site infections compared to traditional large stitch techniques. This approach has been found to be more effective in midline abdominal closures, suggesting potential benefits for liver surgery as well.
12345Is the short stitch technique for suturing generally safe for humans?
Research suggests that using small stitches in suturing can reduce the risk of surgical site infections and incisional hernias, which are common complications after surgery. This indicates that the technique is generally safe and may even offer some benefits over traditional methods.
12367How does the Short Stitch Suture treatment differ from other treatments for preventing incisional hernia after liver surgery?
The Short Stitch Suture treatment is unique because it uses smaller stitches, which have been shown to reduce the risk of incisional hernia and surgical site infections compared to traditional larger stitches. This technique involves a continuous suturing method with a specific suture-to-wound length ratio, aiming to optimize abdominal wall closure and minimize complications.
13489Eligibility Criteria
This trial is for adults over 18 who are scheduled for elective liver tumor surgery (hepatectomy) due to cancer, between May 2021 and November 2024. They must be planning to have a specific type of incision made. Pregnant women, those with prior mesh placement from past surgeries, or pre-existing abdominal hernias cannot participate.Inclusion Criteria
I am planning to have elective surgery.
I am scheduled for surgery with a specific type of incision.
I am scheduled for or have had a liver surgery for cancer between May 1, 2021, and November 1, 2024.
+1 more
Exclusion Criteria
Pregnant women
I have a hernia in my abdomen.
I have had mesh placed in a previous abdominal surgery.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Patients undergo hepatectomy using either small bites or conventional fascial closure method
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Visits at 1-4 weeks, 3, 6, and 12 months
Participant Groups
The study is testing two surgical techniques used to close the incision after liver surgery: short stitch suture versus traditional suture. The goal is to determine which method better prevents an incisional hernia—a bulge through the site where the skin was cut.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (hepatectomy using small bites fascial closure)Experimental Treatment2 Interventions
Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
Group II: Arm II (hepatectomy using conventional fascial method)Active Control2 Interventions
Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Effects of the short-stitch technique for midline abdominal closure: short-term results from the randomised-controlled ESTOIH trial. [2022]The 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.
Closure of midline laparotomies by means of small stitches: practical aspects of a new technique. [2022]Randomized studies support the closure of midline incisions with a suture length to wound length ratio (SL:WL) of more than 4, accomplished with small tissue bites and short stitch intervals to decrease the risk of incisional hernia and wound infection. We investigated practical aspects of this technique possibly hampering the introduction of this technique. Patient data, operative variables and SL:WL ratio were collected at two hospitals: Sundsvall Hospital (SH) and Erasmus University Medical Center (EMC). A structured implementation of the technique had been performed at SH but not at EMC. Personnel were interviewed by questionnaire. At each hospital, 18 closures were analyzed. Closure time was significantly longer (p = 0.023) at SH (median 18 minutes, range: 9-59) than at EMC (median 13 minutes, range: 5-23). An SL:WL ratio of more than 4 was achieved in 8 of 18 cases at EMC and in all 18 cases at SH. We conclude that calculation of an SL:WL ratio is easily performed. Suturing with the small bite-short stitch interval technique of SH required 5 minutes extra, outweighing the morbidity of incisional hernia. Without a structured implementation to suture with an SL:WL ratio of more than 4, a lower ratio is often achieved.
Cost analysis of the use of small stitches when closing midline abdominal incisions. [2022]Suturing with small stitches instead of with large reduces the risk for surgical site infection and incisional hernia in continuously closed midline abdominal incisions. The purpose was to analyse if using small stitches generated cost savings.
Mass Continuous Suture versus Layered Interrupted Suture in Transverse Abdominal Incision Closure after Liver Resection. [2019]Abdominal incision closure technique seriously influences patient prognosis. Most studies have focused on the different suture techniques and materials on midline incision, while little data are available in wide transverse or oblique incisions after liver resection (LR). The aim of the present study is to compare the two major incision suture methods after LR in our institute: Mass continuous suture (group P) and layered interrupted suture (group S).
Small bite versus large bite stitching technique for midline laparotomy wound closure: A systematic review and meta-analysis. [2023]Mass closure with a continuous suture using large bite stitching technique has been widely accepted for midline laparotomy wound closures. However, emerging evidence suggests the use of small bite technique to reduce rates of incisional ventral hernia, surgical site infection (SSI) and burst abdomen. This meta-analysis aims to compare small versus large bite stitching techniques to assess complication rates in midline laparotomy wound closures. A comprehensive multi-database search (OVID EBM Reviews, OVID Medline, EMBASE, Scopus) was conducted from database inception to 11th October 2021 according to PRISMA guidelines. We included studies comparing post-operative complication rates of small bite versus large bite stitching techniques for midline laparotomy wound closure. Extracted data was pooled for meta-analysis evaluating rates of incisional ventral hernia, SSI and burst abdomen. We included five randomized controlled trials (RCT) in the meta-analysis and three prospective cohort studies for qualitative analysis. A total of 1977 participants composed of 961 small bite and 1016 large bite technique patients were included from the five RCTs. There was a significant reduction in the rates of incisional ventral hernia and SSI with the small bite stitch technique with odds ratios (OR) of 0.39 (95% CI [0.21-0.71]) and 0.68 (95% CI [0.51-0.91]) respectively, and a trend in favour of reduced incidence of burst abdomen with OR of 0.60 (95% CI [0.15-2.48]). Small bite stitch technique in midline laparotomy wound closure may be superior over conventional mass closure using the large bite stitch technique, with statistically significant lower rates of incisional ventral hernia and SSI.
Comparison of post-operative pain in short versus long stitch technique for abdominal wall closure after elective laparotomy: a double-blind randomized controlled trial. [2021]Conventional mass closure uses suture-to-wound length ratio of 4:1 ('long stitch', LS). 'Short stitch' (SS) has a suture-to-wound length ratio of more than 4 and incorporates only the linea alba, which may reduce tension and pain. We compared the post-operative pain after laparotomy closure using LS and SS.
Suturable mesh better resists early laparotomy failure in a cyclic ball-burst model. [2021]The small bites surgical technique supported by the STITCH trial has been touted as a strategy for preventing early laparotomy dehiscence through greater force distribution at the suture-tissue interface. However, this hernia prevention strategy requires an alteration in the standard closure technique that has not been widely adopted in the USA. This study seeks to determine whether incorporating a mid-weight polypropylene mesh material into a hollow-bore surgical suture material will effectively increase the force distribution at the suture-tissue interface and potentially help prevent early laparotomy dehiscence in an ex vivo model.
[Laparotomy closure - do we know how?(Guideline of the European Hernia Society)]. [2018]The recurrence rate of surgical treatment of incisional hernia is high. The material and surgical technique used to close the abdominal wall following every surgery contribute as important risk factors in incisional hernia formation. However, by optimising abdominal wall closure, many patients can be spared from developing this type of complication. The European Hernia Society has established a Guidelines Development Group with a goal to research the literature and write a series of recommendations of how to close the abdomen and minimize the risk of incisional hernia in accordance with the principles of evidence-based medicine. To decrease the incidence of incisional hernias, the following is recommended: To utilise a non-midline approach to a laparotomy whenever possible. To perform a continuous suturing technique using a slowly absorbable monofilament suture in a single layer aponeurotic closure technique. To perform the small bites technique with a suture to wound length (SL/WL) ratio at least 4/1. Not to close the peritoneum separately. To avoid rapidly resorbable materials. To consider using a prophylactic mesh in high-risk patients. To use the smallest trocar size adequate for the procedure and closing the fascial defect if trocars larger or equal to 10 mm are used in laparoscopic surgery. Key words: incisional hernia laparotomy laparotomy closure suturing material.
Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial. [2022]Based on a recent meta-analysis, a continuous suture technique with a suture to wound length ratio of at least 4:1, using a slowly absorbable monofilament suture material, is recommended for primary median laparotomy closure. Incisional hernia, which develops in 9 to 20% of patients, remains the major complication of abdominal wall closure. Current clinical data indicate that the incidence of incisional hernias increases by 60% between the first and the third year after median laparotomy, implicating that a follow-up period of 1 year postoperatively is too short with regard to this common complication. Trauma to the abdominal wall can be reduced by improvements in suture technique as well as suture material. Several factors, such as stitch length, suture tension, elasticity, and tensile strength of the suture material are discussed and currently under investigation. A Swedish randomized controlled trial showed a significant reduction in the incisional hernia rate by shortening the stitch length. However, a non-elastic thread was used and follow-up ended after 12 months. Therefore, we designed a multicenter, international, double-blinded, randomized trial to analyze the influence of stitch length, using an elastic, extra-long term absorbable monofilament suture, on the long term clinical outcome of abdominal wall closure.