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Transanal specimen extraction in totally laparoscopic colorectal cancer surgery: a multi-center randomized controlled trial

Transanal specimen extraction in totally laparoscopic colorectal cancer surgery: a multi-center randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036314
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-08-31
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Interventions

Sponsors

Cancer Hospital, Chinese Academy of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Adult males and females, aged between 18 to 75 years old; 2. Colonoscopy biopsy pathologically confirmed colorectal adenocarcinoma; 3. Preoperative colonoscopy or imaging diagnosis of tumor in the sigmoid colon or upper rectum; 4. The preoperative clinical diagnosis is T1-3NxM0; 5. The maximum diameter of the tumor diagnosed by preoperative imaging is not more than 5cm; 6. BMI<=30kg/m2; 7. No local complications before operation (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, abscess formation, no local invasion); 8. The function of heart, lung, liver, kidney and bone marrow meets the requirements of surgery and anesthesia; 9. signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Past history of malignant colorectal tumors; 2) Simultaneous diagnosis of multiple primary colorectal tumors; 3) Preoperative imaging revealed cancerous nodules implanted; 4) There are contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency; 5) Those who have undergone abdominal and pelvic surgery many times in the past or have extensive abdominal adhesions; 6) Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery; 7) The primary tumor invades the abdominal wall and/or adjacent organs, which makes R0 resection impossible; 8) Patients with familial adenomatous polyposis, Lynch syndrome-related cancer, and active inflammatory bowel disease; 9) Diagnosis of other malignant tumors in the past 5 years; 10) ASA grade >=grade IV and/or ECOG physical status score >=2 points; 11) Those with severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery; 12) Have a history of severe mental illness; 13) Pregnant or lactating women; 14) Those with uncontrolled infection before surgery; 15) Patients with other clinical and laboratory conditions considered by the researcher should not participate in the trial; 16) Those who have had anal disease causing abnormal anal function or anal stenosis.

Design outcomes

Primary

MeasureTime frame
3-year disease-free survival;

Countries

China

Contacts

Public ContactXishan Wang

Cancer Hospital, Chinese Academy of Medical Science

wxshan1208@126.com+86 13552367779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026