Clinical trial · Interventional

TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy.

Transanal Minimally Invasive TME (TaTME) Versus Open Intersphincteric Resection and Total Mesorectal Excision of Stage II/III Ultralow Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy.

NCT01836926CI-TRIAL-00044953TaTMEcompletedN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The two surgical options for lower 1/3 rectal cancer is APR and sphincter sparing procedures. Intersphincteric resection is procedure to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy,improves the quality of life with better genitourinary function. Neoadjuvant chemo-radiotherapy is routine for T3 cases.

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 (2)

Intervention	Type	Mapped drug	Match
Open intersphincteric resection	Procedure	—	UNRESOLVED
transanal minimally invasive intersphincteric resection	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Open intersphincteric resection
description
surgical Instruments for open approach intervention: Open laparotomy through abdominal incision and mobilization of the colon and rectum up to the splenic flexure with high ligation of the inferior mesenteric vessels and mesorectal excision till the levator ani then the peranal approach to resect the distal margin of the rectum through high or low intersphincteric resection in the plane between internal and external anal sphincters.
interventionNames
1. Procedure: Open intersphincteric resection
type
ACTIVE_COMPARATOR
label
laparoscopic intersphincteric resection .
description
instruments used: 4 or 5 laparoscopic trocars (two or three (10-mm) trocar, Two 5-mm trocars and a 12-mm trocar with reducers),Three 5-mm fenestrated grasping forceps, Five-millimetre coagulating shears, a 5-mm straight grasping forceps, Harmonic scalpel, 5 or 10 mm, a 10-mm fenestrated forceps, a 10-mm dissector,5 mm Bipolar grasper, a 5-mm needle holder, Twelve-millimetre linear staplers intervention: 1. Trocar Placement and Exposure 2. Rectosigmoid Mobilization and Control of Inferior Mesenteric Vessels 3. Taking Down the Splenic Flexure 4. rectal dissection till the levator ani muscle and resection of thye lateral ligaments then the peranal phase as in the laparotomy approach.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients with low rectal carcinoma(The lowest margin of tumor located 3 cm from anal verge ; ≤ 2 cm from dentate lines; 1 cm from anorectal rings.
* Local spread restricted to the rectal wall or the internal anal sphincter.
* Adequate preoperative sphincter function and continence.
* Absence of distant metastasis.

Exclusion Criteria:

* Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4.
* Metastatic rectal cancer.
* Those in Dukes stage D (T4 lesion).
* Undifferentiated tumours.
* Local infiltration of external anal sphincter or levator ani muscles.
* Tumor located more than 2 cm above the dentate line.
* Presence of fecal incontinence.
* Patients unwilling to take part in the study.

References

Publications (1)

RESULT[1] Zeeneldin A, Saber M, Seif El-din I, Frag S. Colorectal carcinoma in Gharbiah district, Egypt: Comparison between the elderly and non-elderly. Journal of Solid Tumors 2012; Vol. 2, No. 3. [2] Heald RJ, Husband EM, Ryall RD The mesorectum in rectal cancer surgery-the clue to pelvic recurrence? Br J Surg 1982; 69:613-616 [3] Daniels IR, Fisher SE, Heald RJ, Moran BJ. Accurate staging, selective preoperative therapy and optimal surgery improves outcome in rectal cancer: a review of the recent evidence. Colorectal Dis 2007; 9: 290-301. [4] Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S et al. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet 2009; 373: 811-820. [5] Bai X., Li S., Yu B., Su H., Jin W., Chen G., Du J. And Zuo F. Sphincter-preserving surgery after preoperative radiochemotherapy for T3 low rectal cancers. Oncology Letters 2012; 3: 1336-1340 [6] Tytherleigh MG and Mortensen MN. Options for sphincter preservation in surgery for low rectal cancer , British Journal of Surgery 2003; 90: 922-933 DOI: 10.1002/bjs.4296 [7] Schiessel R, Karner-Hanusch J, Herbst F, Teleky B, Wunderlich M. Intersphincteric resection for low rectal tumours. Br J Surg 1994; 81: 1376-1378. [8] Kapiteijn E, Marijnen CA, Nagtegaal ID et al Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med 2001; 345:638-646

Registry

Dates and enrollment

Start: Apr 1, 2013
Primary completion: Jul 1, 2019
Completion: Jul 1, 2019
First posted: Apr 22, 2013
Last update posted: May 5, 2020
Enrollment: 110 (actual)
Lead sponsor: Osama Mohammad Ali ElDamshety OTHER
Collaborators: Mansoura University; Marche Polytechnic university, Ancona, Italy
Keywords: sphincter sparing procedures, intersphincteric resection, rectal cancer, ultralow rectal cancer, sphincter preserving procedures, Abdominoperineal resection, Trans-anal minimally invasive surgery, TAMIS versus open colorectal resection, neoadjuvant chemo-radiotherapy for rectal cancer

Data updated 22 days agoSource updated May 5, 2020source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
Egypt	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.