Suture Techniques for Preventing Incisional Hernia After Liver Surgery

Overseen By Timothy E Newhook, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Abdominal hernia, Mesh placement, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 week

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of two surgical techniques better prevents hernias, or holes in the abdomen, after liver tumor surgery. Researchers compare the "short stitch" method (Short Stitch Suture) with a traditional stitching technique (Traditional Suture) to identify the more effective option. This trial suits individuals planning liver surgery due to cancer, involving either a midline or inverted-L incision. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.

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 prior data suggests that these suture techniques are safe for liver surgery?

Research shows that the short stitch suture technique is well-tolerated. Studies have found that smaller stitches can lower the risk of infections and hernias at the surgery site, common complications after surgery. Patients who underwent this technique had a significantly reduced chance of hernias one year post-surgery, suggesting it is a safe option for closing surgical wounds.

In contrast, the traditional suture technique is widely used and has a well-known safety record. As the standard method for closing surgical cuts, it has been employed in many surgeries, indicating it is generally considered safe, with risks similar to those of most surgeries.

Both techniques aim to close the surgical site effectively and safely. However, the short stitch method might offer extra benefits in reducing complications like hernias and infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative suture techniques to prevent incisional hernias after liver surgery. The trial compares a short stitch suture technique, which uses small bites for abdominal wall closure, to the traditional suture method. This small bites technique could potentially offer stronger wound healing and reduced risk of hernia, as it aims for more precise tissue approximation and less tension across the incision. If successful, these findings could lead to improved surgical outcomes and fewer complications for patients undergoing liver surgery.

What evidence suggests that these suture techniques are effective for preventing incisional hernia after liver surgery?

Research shows that the short stitch suture technique, which participants in this trial may receive, can lower the risk of developing an incisional hernia (a hole at the surgery site) and infections at the surgery site. Studies have found that this technique reduces hernia rates more effectively than traditional methods. One study reported that using smaller stitches significantly decreased the chances of hernias and infections. Another study showed that the hernia rate with short stitches was lower than with larger stitches. Overall, these findings suggest that the short stitch suture might be more effective in preventing complications after liver surgery. Meanwhile, the traditional suture technique, another option in this trial, serves as a comparison to evaluate the effectiveness of the short stitch method. ^{1 2 4 6 7}

Who Is on the Research Team?

Timothy Newhook, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Pregnant women

I have a hernia in my abdomen.

I have had mesh placed in a previous abdominal surgery.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Short Stitch Suture
• Traditional Suture

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm I (hepatectomy using small bites fascial closure) Experimental Treatment 2 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 Control 2 Interventions

Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 258 patients undergoing liver resection, the mass continuous suture technique resulted in significantly shorter incision closure times compared to the layered interrupted suture technique.

While both suture methods showed similar rates of postoperative wound complications, the mass continuous suture technique appeared to promote faster wound healing, suggesting it may be a more efficient option for abdominal incision closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mass Continuous Suture versus Layered Interrupted Suture in Transverse Abdominal Incision Closure after Liver Resection. Zhang, J., Zhang, HK., Zhu, HY., et al.[2019]

In a study of 86 patients undergoing elective midline laparotomy, the 'short stitch' (SS) technique did not significantly reduce post-operative pain compared to the conventional 'long stitch' (LS) method, as measured by morphine usage and pain scores.

However, patients in the SS group had a shorter length of hospital stay (median of 6 days) compared to the LS group (median of 8 days), suggesting a potential benefit of the SS technique in recovery time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of post-operative pain in short versus long stitch technique for abdominal wall closure after elective laparotomy: a double-blind randomized controlled trial. Lai, LW., Roslani, AC., Yan, YW., et al.[2021]

In a study involving 425 patients, the short-stitch technique for closing midline laparotomies showed a trend towards a lower rate of burst abdomen (1.40% vs. 4.76%) compared to the long-stitch technique, suggesting it may be safer.

While the differences in short-term surgical outcomes were not statistically significant, the short-stitch group demonstrated a significantly lower risk of burst abdomen, indicating potential benefits of this technique in preventing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the short-stitch technique for midline abdominal closure: short-term results from the randomised-controlled ESTOIH trial. Albertsmeier, M., Hofmann, A., Baumann, P., et al.[2022]

A meta-analysis of five randomized controlled trials involving 1977 participants found that the small bite stitching technique for midline laparotomy wound closures significantly reduces the rates of incisional ventral hernia and surgical site infections (SSI) compared to the large bite technique, with odds ratios of 0.39 and 0.68, respectively.

The small bite technique also showed a trend towards a lower incidence of burst abdomen, suggesting it may be a safer option for wound closure in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small bite versus large bite stitching technique for midline laparotomy wound closure: A systematic review and meta-analysis. Yii, E., Onggo, J., Yii, MK.[2023]

Optimizing abdominal wall closure techniques can significantly reduce the risk of incisional hernias after surgery, with recommendations including using a non-midline approach and a continuous suturing technique with slowly absorbable materials.

The European Hernia Society suggests specific practices such as avoiding separate closure of the peritoneum and considering prophylactic mesh for high-risk patients to further minimize hernia formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Laparotomy closure - do we know how?(Guideline of the European Hernia Society)]. East, B., Muysoms, FE.[2018]

A structured implementation of the small bite-short stitch interval technique at Sundsvall Hospital resulted in achieving a suture length to wound length (SL:WL) ratio of more than 4 in all cases, which is important for reducing the risk of incisional hernia and wound infection.

Although the closure time was longer at Sundsvall Hospital (median 18 minutes) compared to Erasmus University Medical Center (median 13 minutes), the benefits of achieving a higher SL:WL ratio outweighed the additional time, highlighting the importance of proper technique in surgical closures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closure of midline laparotomies by means of small stitches: practical aspects of a new technique. van Ramshorst, GH., Klop, B., Hop, WC., et al.[2022]

Using small stitches for closing midline abdominal incisions significantly reduces the incidence of incisional hernias compared to large stitches, with only 11 hernias occurring in 321 patients versus 45 in 370 patients.

Despite a slightly longer suturing time with small stitches, the overall cost savings from reduced hernia repairs amounted to 1,339 SEK per patient from a societal perspective, making this technique economically beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost analysis of the use of small stitches when closing midline abdominal incisions. Millbourn, D., Wimo, A., Israelsson, LA.[2022]

In an ex vivo study using 28 porcine abdominal wall specimens, the incorporation of mid-weight polypropylene mesh (0 DuraMesh™) into surgical sutures significantly increased the force distribution at the suture-tissue interface, resulting in a higher maximal force before suture pull-through compared to conventional sutures.

The mean maximal force for the DuraMesh suture group was 850.1 N, significantly greater than the 714.7 N observed with standard polydioxanone sutures, suggesting that this innovative suture design could help prevent early laparotomy dehiscence and incisional hernias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suturable mesh better resists early laparotomy failure in a cyclic ball-burst model. Scheiber, CJ., Kurapaty, SS., Goldman, SM., et al.[2021]

A multicenter, double-blinded randomized trial involving 468 patients will compare short versus long stitch techniques for abdominal wall closure after median laparotomy, focusing on the long-term incidence of incisional hernias, which can occur in 9 to 20% of patients.

The study aims to determine if using an elastic, extra-long term absorbable suture with a short stitch technique can reduce the rate of incisional hernias compared to the traditional long stitch method, with follow-up assessments extending up to 5 years post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial. Fortelny, RH., Baumann, P., Thasler, WE., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12397119/

5-year clinical outcome of the ESTOIH trial comparing ... The incisional hernia rate increased in the short-bite group from 7.58% to 9.14% (p = 0.58) and in the large-bite group from 10.45% to 13.90% (p ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04982653

Short Stitch Versus Traditional Suture for the Prevention of ... This clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11297062/

Three-year follow-up analysis of the short-stitch versus ... Clinical trials have shown reduced incisional hernia rates 1 year after elective median laparotomy closure using a short-stitch technique.

4. sciencedirect.com sciencedirect.com/science/article/pii/S101595842301285X

Small bite versus large bite stitching technique for midline ... 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 ...

5. withpower.com withpower.com/trial/phase-3-liver-neoplasms-9-2021-7ef45?fbclid=IwZXh0bgNhZW0CMTEAAR6dxSIYD_3wkDU_D34ir03hE9XI9uRwBT0uSrAjTPEn4EcTYI2UnLiL6zW7kA_aem_2fMP-4PBGoc6H8vrNV80Cg

Suture Techniques for Preventing Incisional Hernia After ... Research shows that using small stitches and short stitch intervals can reduce the risk of incisional hernia and surgical site infections compared to ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/wjs.12619

Small Bites Versus Large Bites for Closure of Midline ... Our findings demonstrated that the small-bite suturing technique significantly reduced the incidence of ventral hernias 1-year post-surgery ...

7. cinj.org cinj.org/sites/cinj/files/documents/Small%20bites%20versus%20large%20bites%20for%20closure%20of%20abdominal%20midline%20incisions%20(STITCH)%20-%20a%20double-blind,%20multicentre,%20randomised%20controlled%20trial.pdf

Small bites versus large bites for closure of abdominal ... Our findings confirm the effectiveness of the small bites suture technique for prevention of incisional hernia. The small bites technique ...