Clinical trial · Interventional
The Efficacy of a Topical Anti-adhesive Film for Decreasing Perihepatic Adhesions in Repeat Hepatic Surgery
NCT04641923CI-TRIAL-00051515unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There has been an increase in the need for repeat hepatic surgery, especially for patients with colorectal liver metastasis and hepatocellular carcinoma. Adhesions at the time of repeat surgery can lead to increased operative times, higher blood loss and even increased perioperative morbidity. Not much data exists regarding use of anti-adhesion barriers at the time of index hepatectomy and their effect on adhesions at repeat hepatectomy. This randomized controlled trial aims to evaluate the effectiveness of the use of a hyaluronan and cellulose based antiadhesive topical film at index hepatectomy in reducing perihepatic adhesions at the time of repeat hepatic surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adhesion | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adhesion barrier | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Seprafilm
- description
- Antiadhesion barrier applied
- interventionNames
- Other: Adhesion barrier
- type
- NO_INTERVENTION
- label
- No seprafilm
- description
- No barrier applied
Primary outcomes (1)
- measure
- Incidence of peri-hepatic adhesions at the time of repeat liver surgery
- timeFrame
- 0-4 years from initial surgery, time of repeat surgery will vary from patient to patient
- description
- Evaluation will be performed at second surgery as follows: Calgary Scoring System Grade1-No adhesions, Grade2-Mild, Grade3-Moderate, Grade4-Severe adhesions, Grade5-severe adhesions with injury to other organs TORanomon Adhesion score (TORAD score): * Hepatic Hilum * 1-Easy: Easy for encircling the hepatoduodenal ligament (HDL) * 2-Hard: Additional maneuver for encircling HDL * 3-Extreme: Safe encircling of HDL is impossible * Liver Surface * 1-Easy: No adhesion * 2-Hard: Presence of dense fibrosis or scarring tissue- hard dissection * 3-Extreme): Dense scar with unclear boundary with the surrounding organs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing partial hepatectomy with high likelihood of needing repeat hepatectomy (e.g. those with colorectal liver metastasis and hepatocellular carcinoma) 2. Patients ≥ 18 years of age. Exclusion Criteria: 1. Patients unable to provide informed consent. 2. Patients with hypersensitivity to Seprafilm and/or to any components of the Seprafilm. 3. Patients who are found to have unresectable disease during surgery (additional hepatic lesions or extrahepatic metastatic disease precluding liver resection
References
Publications (15)
- RESULTWeibel MA, Majno G. Peritoneal adhesions and their relation to abdominal surgery. A postmortem study. Am J Surg. 1973 Sep;126(3):345-53. doi: 10.1016/s0002-9610(73)80123-0. No abstract available. PMID 4580750
- RESULTSchnuriger B, Barmparas G, Branco BC, Lustenberger T, Inaba K, Demetriades D. Prevention of postoperative peritoneal adhesions: a review of the literature. Am J Surg. 2011 Jan;201(1):111-21. doi: 10.1016/j.amjsurg.2010.02.008. PMID 20817145
- RESULTArung W, Meurisse M, Detry O. Pathophysiology and prevention of postoperative peritoneal adhesions. World J Gastroenterol. 2011 Nov 7;17(41):4545-53. doi: 10.3748/wjg.v17.i41.4545. PMID 22147959
- RESULTKobayashi Y, Shindoh J, Igata Y, Okubo S, Hashimoto M. A novel scoring system for evaluating the difficulty of lysis of adhesion and surgical risk at repeat hepatectomy. J Hepatobiliary Pancreat Sci. 2020 Apr;27(4):191-199. doi: 10.1002/jhbp.708. Epub 2020 Feb 14. PMID 31944589
- RESULTAhmad G, O'Flynn H, Hindocha A, Watson A. Barrier agents for adhesion prevention after gynaecological surgery. Cochrane Database Syst Rev. 2015 Apr 30;2015(4):CD000475. doi: 10.1002/14651858.CD000475.pub3. PMID 25924805
- RESULTShimizu A, Hasegawa K, Masuda K, Omichi K, Miyata A, Kokudo N. Efficacy of Hyaluronic Acid/Carboxymethyl Cellulose-Based Bioresorbable Membranes in Reducing Perihepatic Adhesion Formation: A Prospective Cohort Study. Dig Surg. 2018;35(2):95-103. doi: 10.1159/000472883. Epub 2017 May 12. PMID 28494442
- RESULTKumar S, Wong PF, Leaper DJ. Intra-peritoneal prophylactic agents for preventing adhesions and adhesive intestinal obstruction after non-gynaecological abdominal surgery. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD005080. doi: 10.1002/14651858.CD005080.pub2.