Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma

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Detailed Description

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Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lap, 1

Patients undergoing laparoscopic surgery for rectal carcinoma

Group Type EXPERIMENTAL

laparoscopic surgery for rectal carcinoma

Intervention Type PROCEDURE

Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (\<8 cm).

Interventions

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laparoscopic surgery for rectal carcinoma

Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (\<8 cm).

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic rectal resection

Eligibility Criteria

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Inclusion Criteria

1. Histologically proven rectal carcinoma.
2. Tumor located in the rectum.
3. Clinical Tis, T1, T2 N0 M0
4. Without multiple lesions other than carcinoma in situ
5. Tumor size \<8 cm.
6. Sufficient organ function.
7. No bowel obstruction.
8. No history of major colorectal surgery.
9. No history of chemotherapy or radiotherapy.
10. Provide written informed consent.

Exclusion Criteria

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
2. Pregnant or lactating women.
3. Severe mental disease.
4. Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
5. Continuous systemic steroid therapy.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No