Clinical trial · Interventional
Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
A Multicenter Prospective Randomized Study Comparing Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding issues
Summary
Brief summary (as posted)
We hypothesize that hand-assisted laparoscopy will overcome technical difficulties related to pure laparoscopic rectal surgery and allow surgeons to expand application of laparoscopic techniques to treating patients with rectal cancer. In this study, we plan to randomly assign patients diagnosed with rectal cancer to undergo either "standard" laparoscopic surgery or hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term outcomes of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HAL proctectomy | Procedure | — | UNRESOLVED |
| Hand-assisted laparoscopic proctectomy | Procedure | — | UNRESOLVED |
| SL Proctectomy | Procedure | — | UNRESOLVED |
| "straight" laparoscopic proctectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- HAL Proctectomy
- description
- Hand-assisted laparoscopic proctectomy
- interventionNames
- Procedure: HAL proctectomy
- Procedure: Hand-assisted laparoscopic proctectomy
- type
- ACTIVE_COMPARATOR
- label
- SL Proctectomy
- description
- "straight" laparoscopic proctectomy
- interventionNames
- Procedure: "straight" laparoscopic proctectomy
- Procedure: SL Proctectomy
Primary outcomes (1)
- measure
- operative time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> = 18 years of age * Histologically proven rectal cancer * Inferior margin of the cancer located within 15 cm from the anal verge as determined by rigid sigmoidoscopy * No evidence of distant metastases * Childbearing age women with negative pregnancy test * Patient is a candidate for elective rectal resection * The patient, or their representative, is able to understand the study and is willing to consent to participation in the study. Exclusion Criteria: * Age \< 18 years of age * Surgically unresectable rectal cancer * Patients who will require APR or hand-sewn colo-anal anastomosis * ASA class 4 or 5 * Patients having additional surgical procedures which may have affect recovery * Child bearing age women with positive pregnancy test * Patients with contraindication for treatment by laparoscopy * Patients or their representative who are unable to understand the conditions and objectives of the study
References
Publications (0)
Data not yet available