Liver and Intrahepatic Bile Duct NeoplasmPhase 2NCT04982653
Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy
A Phase 2 study testing Quality-of-Life Assessment and Surgical Procedure in people with Liver and Intrahepatic Bile Duct Neoplasm and Metastatic Malignant Neoplasm in the Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver and Intrahepatic Bile Duct Neoplasm, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm
- What is being tested?
- Quality-of-Life Assessment and Surgical Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 2 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pre-existing abdominal hernia
- History of mesh placement at prior laparotomy
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Timothy E. Newhook, 713-792-6940, TNewhook@mdanderson.org
Timothy E. Newhook
About this study
Official title: Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess whether small bites abdominal wall closure reduces the risk of developing incisional hernia following liver surgery.
SECONDARY OBJECTIVES:
- To compare short-term perioperative outcomes between small bites and typical fascial closure technique.
II. To assess the hernia incidence rate of short stich versus (vs.) standard closure in subgroups of patients with inverted-L or midline incisions.
III. To assess the hernia incidence rate of Kawaguchi-Gayet hepatectomy complexity classifications I/II vs. III (hernia rate by extent of hepatectomy).
IV. To assess the hernia incidence rate of preoperative chemotherapy or no preoperative chemotherapy (hernia rate by exposure to preoperative chemotherapy).
- To assess impact of small bites abdominal wall closure on health care quality of life following liver surgery.
VI. To assess safety of small tissue bites fascial closure suture technique versus conventional fascial closure following hepatectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION): Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
ARM II (CONTROL): Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
After completion of study, patients are followed up at 1-4 weeks, and then at 3, 6, and 12 months.
- Conditions
- Liver and Intrahepatic Bile Duct Neoplasm, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm
- Being tested
- Quality-of-Life Assessment, Surgical Procedure
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgical, Surgical Intervention
Undergo hepatectomy using small bites fascial method for abdominal wall closure
Surgical ProcedureProcedure or surgery
Also called Operation, Surgery, Surgical, Surgical Intervention
Undergo hepatectomy using conventional fascial method for abdominal wall closure
| Study group | Role | What they receive |
|---|---|---|
| Arm I (hepatectomy using small bites fascial closure) | Experimental | Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure. Receives: Other: Quality-of-Life Assessment; Procedure: Surgical Procedure |
| Arm II (hepatectomy using conventional fascial method) | Active comparator | Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure. Receives: Other: Quality-of-Life Assessment; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months after surgery
Secondary outcomes (10)
Surgical site infection
Measured: Up to 90 days after surgery
Surgical site occurrence
Measured: Up to 90 days after surgery
Surgical site occurrence requiring procedural intervention
Measured: Up to 90 days after surgery
Postoperative complications
Post-operative infection, complication or pain will be assessed using Chi-squared test or Fisher's exact test.
Measured: Up to 90 days after surgery
Need for reoperation
Measured: Up to 90 days after surgery
Need for reoperation secondary to complication of abdominal closure
Measured: Up to 90 days after surgery
Length of hospital stay (postoperatively)
Will be compared between the two arms using two-sample t-test or Wilcoxon rank sum test.
Measured: Up to 90 days after surgery
Any readmission related to hernia repair
Measured: Up to 30 days after surgery
Health-related quality of life assessment
Will use linear mixed effect modeling to assess the effects of time, arm as well as the interaction between arm and time.
Measured: Up to 12 months after surgery
Incidence of adverse events (AEs)
Will be summarized using descriptive statistics (frequency, percentage) by arm, AE type, severity and attribution.
Measured: Up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start4 Jan 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver and Intrahepatic Bile Duct NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy E Newhook, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982653
- Sponsor's protocol ID
- 2021-0254
- Other IDs
- NCI-2021-04402, 2021-0254
- Status last verified
- May 2026
- First submitted
- 18 Jun 2021
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04982653
- Acronym / sponsor ID
- 2021-0254
- Conditions
- Liver and Intrahepatic Bile Duct Neoplasm, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To assess whether small bites abdominal wall closure reduces the risk of developing incisional hernia following liver surgery.
SECONDARY OBJECTIVES:
- To compare short-term perioperative outcomes between small bites and typical fascial closure technique.
II. To assess the hernia incidence rate of short stich versus (vs.) standard closure in subgroups of patients with inverted-L or midline incisions.
III. To assess the hernia incidence rate of Kawaguchi-Gayet hepatectomy complexity classifications I/II vs. III (hernia rate by extent of hepatectomy).
IV. To assess the hernia incidence rate of preoperative chemotherapy or no preoperative chemotherapy (hernia rate by exposure to preoperative chemotherapy).
- To assess impact of small bites abdominal wall closure on health care quality of life following liver surgery.
VI. To assess safety of small tissue bites fascial closure suture technique versus conventional fascial closure following hepatectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (INTERVENTION): Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.
ARM II (CONTROL): Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.
After completion of study, patients are followed up at 1-4 weeks, and then at 3, 6, and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (hepatectomy using small bites fascial closure) | Experimental | Other: Quality-of-Life Assessment, Procedure: Surgical ProcedurePatients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure. |
| Arm II (hepatectomy using conventional fascial method) | Active comparator | Other: Quality-of-Life Assessment, Procedure: Surgical ProcedurePatients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pre-existing abdominal hernia
- History of mesh placement at prior laparotomy
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (hepatectomy using small bites fascial closure), Arm II (hepatectomy using conventional fascial method) |
| Surgical ProcedureAlso: Operation, Surgery, Surgical, Surgical InterventionUndergo hepatectomy using small bites fascial method for abdominal wall closure | Procedure or surgery | Arm I (hepatectomy using small bites fascial closure) |
| Surgical ProcedureAlso: Operation, Surgery, Surgical, Surgical InterventionUndergo hepatectomy using conventional fascial method for abdominal wall closure | Procedure or surgery | Arm II (hepatectomy using conventional fascial method) |
Primary outcome
Radiographic incidence rate of incisional hernia
Time frame: Up to 12 months after surgery
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.
10 secondary outcomes
Surgical site infection
Time frame: Up to 90 days after surgery
Surgical site occurrence
Time frame: Up to 90 days after surgery
Surgical site occurrence requiring procedural intervention
Time frame: Up to 90 days after surgery
Postoperative complications
Time frame: Up to 90 days after surgery
Need for reoperation
Time frame: Up to 90 days after surgery
Need for reoperation secondary to complication of abdominal closure
Time frame: Up to 90 days after surgery
Length of hospital stay (postoperatively)
Time frame: Up to 90 days after surgery
Any readmission related to hernia repair
Time frame: Up to 30 days after surgery
Health-related quality of life assessment
Time frame: Up to 12 months after surgery
Incidence of adverse events (AEs)
Time frame: Up to 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Liver and Intrahepatic Bile Duct Neoplasm
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 2
PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma
Metastatic Colorectal Cancer (Mcrc), Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
RecruitingPhase 2
Additional Chemotherapy Administered Directly Into the Liver Using a Chemo Pump in Patients With Bile Duct Cancer Inside the Liver Treatable by Surgery
Intrahepatic Bile Duct Cancer, Intrahepatic Cholangiocarcinoma (Icc)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy E Newhook, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quality-of-Life Assessment and Surgical Procedure in people with Liver and Intrahepatic Bile Duct Neoplasm and Metastatic Malignant Neoplasm in the Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy E Newhook, MD (713-792-6940, TNewhook@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic incidence rate of incisional hernia (time frame: Up to 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.