SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR

NCT07891091 | Not Yet Recruiting

• 1 other identifier: 2026-01104-01
• Study Type: interventional
• Target: 980
• Locations: 1 country
• Sites: 1

Brief Summary

Incisional hernia is a common condition after abdominal surgery and is often associated with pain, impaired physical function, and reduced quality of life. It may also be complicated by incarceration and strangulation, with the potential for acute and life-threatening events. Surgical repair is the only curative treatment, and in many cases requires complex abdominal wall reconstruction, with substantial morbidity and a risk of recurrence. In recent years, minimally invasive laparoscopic and robot-assisted surgery has gained an increasingly important role in the treatment of ventral hernias. Retromuscular mesh placement combined with closure of the fascial defect has been developed to combine biomechanical principles from open Rives-Stoppa reconstruction with the potential benefits of minimally invasive techniques. A key knowledge gap is which suture material should be used for defect closure: non-absorbable sutures, which provide permanent mechanical stability but leave permanent foreign material, or slowly absorbable sutures, which degrade over time and may reduce suture-related complications. In clinical practice, the choice is often driven by local tradition and surgeon preference rather than robust evidence. Evidence from abdominal wall closure after elective laparotomy supports the use of slowly absorbable suture material; however, those results cannot be directly transferred to minimally invasive ventral hernia surgery where mesh reinforcement, biomechanics, and healing processes differ. Randomized multicenter trials specifically evaluating the impact of suture material in laparoscopic or robot-assisted retromuscular ventral/incisional hernia repair are lacking. Against this background, the present trial compares slowly absorbable versus non-absorbable sutures in minimally invasive retromuscular incisional hernia repair, focusing on an objective long-term endpoint. CT-verified recurrence at 2 years was chosen as the primary endpoint to provide a robust and clinically meaningful measure of treatment effect. The hierarchical hypothesis framework (primary test of superiority and secondary test of non-inferiority) allows a clinically useful interpretation even if no statistically significant advantage is demonstrated. Although incisional hernia is a subset of ventral hernias and shares pathophysiological and surgical principles with other ventral hernias, this trial is restricted to incisional hernia, where recurrence is more common and suture choice is expected to be more decisive. This restriction aims to achieve a more homogeneous study population and improve internal validity

Conditions

Ventral Incisional Hernia

Keywords

RCT; Suture; Non-absorbable sutrure; Absorbable suture; Retromuscular hernia repair; Incisional hernia; MIS

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure - Number of patients with a CT-verified recurrence up to 2 years after surgery

  The primary objective is to evaluate whether the choice of suture material for fascial defect closure in minimally invasive (laparoscopic or robot-assisted) retromuscular incisional hernia repair affects the risk of recurrence, defined as CT-verified recurrence 2 years after surgery. The trial uses a hierarchical framework: first, superiority of non-absorbable versus slowly absorbable suture is tested for 2-year recurrence. If superiority is not demonstrated, non-inferiority of slowly absorbable versus non-absorbable suture is tested within a pre-specified clinically relevant margin.

  From day of surgery up to 24 months postoperatively

Secondary Outcomes (6)

• Perioperative outcomes

  Recorded at day of surgery

• Length of hospital stay

  From admission day (usually day of surgery) up to 30 days postoperatively

• Short-term postoperative complications

  From day of surgery to 30 days postoperatively

• Clinical long-term outcomes

  From day of surgery up to 36 months postoperatively

• Patient-reported long-term outcomes

  From baseline to 36 months postoperatively

Study Arms (2)

Non-absorbable suture

EXPERIMENTAL

Hernia defect sutured with non-absorbable suture

Procedure: Suturing of hernia defect with non-absorbable suture

Slowly absorbable suture

ACTIVE COMPARATOR

Hernia defect sutured with slowly absorbable suture

Procedure: Suturing of hernia defect with slowly absorbable suture

Interventions

Suturing of hernia defect with non-absorbable suture PROCEDURE

During retromuscular minimally invasive surgery for incisional hernia, the hernia defect is closed using the assigned suture type

Non-absorbable suture

Suturing of hernia defect with slowly absorbable suture PROCEDURE

During retromuscular minimally invasive surgery for incisional hernia, the hernia defect is closed using the assigned suture type

Slowly absorbable suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ventral incisional hernia, (EHS TYPE M1-5 and / or L1-4; W1-3).
• Patient planned for minimally invasive (laparoskopic or robo-assisted) retromuscular repair

You may not qualify if:

• Other types of hernia, e.g. parastomal hernia, primary abdominal wall hernia or inguinal hernia
• Severe comorbidity (ASA \> III) or expected survival less than 3 years
• Contraindication to minimally invasive technique
• Ongoing pregnancy
• Emergency surgery with ongoing strangulation
• Inability to understand study information, participate in follow-up according to the study protocol, or provide written informed consent.

Sponsors & Collaborators

• Ersta Diakoni: lead
• Karolinska Institutet: collaborator
• Region Stockholm: collaborator
• Region Västerbotten: collaborator

Study Sites (1)

Ersta Sjukhus

Stockholm, Sweden

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Anders Thorell

  Ersta Diakoni, Karolinska Institutet

  STUDY DIRECTOR

• Mikael Lindmark

  Umeå University

  STUDY DIRECTOR

Central Study Contacts

Henrik Nilsson, MD, PhD

CONTACT

+4687146885; henrik.nilsson@ki.se

Per Lindström, MD

CONTACT

per.lindstrom@erstadiakoni.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2033 t0 2043
• Access Criteria: Data can be shared for systematic reviews and meta- analyses

Locations

SE (1)