Comparing low and high ligation techniques in laparoscopic surgery for rectal cancer

Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery

This study is testing whether two different surgical techniques for rectal cancer can lead to fewer complications and better recovery for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 466 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT03498885 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of two surgical techniques, low and high ligation, during laparoscopic anterior resection for rectal cancer. It aims to determine their impact on postoperative complications such as anastomotic leakage, proximal bowel necrosis, and stenosis, as well as overall quality of life and long-term survival outcomes. By conducting a prospective, multi-center trial, the research seeks to provide definitive guidance for surgeons regarding the optimal approach to ligating the inferior mesenteric artery during surgery. The trial will include patients with rectal or sigmoid adenocarcinoma who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with rectal or sigmoid adenocarcinoma located at specific distances from the dentate line.

Not a fit: Patients with severe cardiovascular disease, uncontrollable infections, or other significant health complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing laparoscopic surgery for rectal cancer.

How similar studies have performed: Previous studies have shown mixed results regarding the benefits of high versus low ligation, indicating that this trial addresses a debated topic in surgical practice.

Eligibility criteria

Inclusion Criteria:

* 18 Years to 75 Years (Adult, Senior).
* Colonoscopy and pathology shows rectal or sigmoid adenocarcinoma.
* Tumor located at 4-15 cm from the dentate line.
* The clinical staging of tumor by MRI within T1-4a when tumor Above the peritoneum and T3N0-2 when tumor below the peritoneum.
* Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery and radical resection is available after neoadjuvant chemotherapy.
* Anus-saving operation is available.
* ASA class: I-III.
* Well tolerate to general anesthesia.
* ECOG score: 0-1.
* Patients - can understand and are willing to take part in the clinical trial.

Exclusion Criteria:

* Severe cardiovascular disease, uncontrollable infection or other severe complications.
* Severe mental illness.
* Suffer with other carcinoma simultaneously or sequentially in 5 years.
* Familial polyposis coli or Multiple -colorectal tumor.
* History of abdominal surgery and with severe abdominal adhesions.
* Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation and emergency surgery is needed.
* Multiple organs resection surgery is needed.
* Abdominoperineal resection need to be performed.
* ASA class: IV to V.
* Pregnant, suckling period or reject to birth control.
* Patient who unable to go through the clinical trial because of familial,social or religious factors.
* Refuse to take part in the trial.
* Patients without an informed consent.
* Non-compliant patient
* The patient or their family members want to withdraw from the clinical trial.
* Loss to follow-up
* Researchers think the participants need to withdraw from the clinical trial.

Where this trial is running

Changsha, Hunan

• Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Wei dong Liu, MD — Xiangya Hospital of Central South University
• Study coordinator: Ting Zou, MD

Conditions Rectal Cancer; inferior mesenteric artery; Laparoscopic