Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing hepatectomy for malignant diagnosis (primary or secondary) from 5/1/2021 through 11/1/2024 will be eligible for inclusion in this study

Elective surgery

Age >= 18

Planned midline laparotomy incision or inverted-L incision

Disqualifiers

Pre-existing abdominal hernia

History of mesh placement at prior laparotomy

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Surgical Procedure

    Procedure/Surgery

    Undergo hepatectomy using small bites fascial method for abdominal wall closure

  • Surgical Procedure

    Procedure/Surgery

    Undergo hepatectomy using conventional fascial method for abdominal wall closure

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Arm I (hepatectomy using small bites fascial closure)Experimental treatment 2 interventions
Group B: Arm II (hepatectomy using conventional fascial method)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Radiographic incidence rate of incisional hernia

Definition of incisional hernia will be based on the European Hernia Society: Any abdominal wall gap with or without a bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging. Assessment of the primary outcome will occur at 3, 6, and 12 months with a computed tomography scan/magnetic resonance imaging. Scans will be read and assessed for incisional hernia by 3 independent assessors blinded to the allocation. A correlation coefficient will be determined for their assessments. The cumulative incidence rate of incisional hernia at 12 months will be estimated, along with the 95% confidence interval.

Time frame
Up to 12 months after surgery

Secondary outcomes

1

Surgical site infection

Time frame
Up to 90 days after surgery
2

Surgical site occurrence

Time frame
Up to 90 days after surgery
3

Surgical site occurrence requiring procedural intervention

Time frame
Up to 90 days after surgery
4

Postoperative complications

Post-operative infection, complication or pain will be assessed using Chi-squared test or Fisher's exact test.

Time frame
Up to 90 days after surgery

Other outcomes

Sponsors and contacts

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