Current Clinical Trials at UIHC: GI Oncology Protocols: Laparoscopic Colectomy

CALGB GI Protocol 9396

James R. Howe, M.D.
Peer Review Status: Internally Peer Reviewed

• Adenocarcinoma of right, left, or sigmoid colon
• non-metastatic, non-emergent

Objective:

• To compare survival in patients undergoing open colectomy
• versus laparoscopic colectomy
• Compare mortality, morbidity, quality of life, and costs

This trial simply compares open versus laparoscopic colectomy in those with cancer of the right, left, or sigmoid colon. Transverse colon lesions are more difficult to remove because of the greater omentum. Patients with obstructive lesions, Stage IV cancers, rectal lesions, or emergent procedures are ineligible.

Endpoints will be DFS and overall survival, morbidity, cost, and quality of life.

The projected accrual is 1200 pts. for the study. In the first 18 months, 131 pts. were accrued. This is an intergroup trial with CALGB, NCCTG, RTOG, SWOG, and ECOG.

Each surgeon must be videotaped doing the procedure prior to them being allowed to enter patients.

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Last Modified: February 26, 1997