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TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy. (TaTME)

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Open intersphincteric resection
transanal minimally invasive intersphincteric resection
Sponsored by
Osama Mohammad Ali ElDamshety
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansoura oncology centre
  • Mansoura university oncology centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open intersphincteric resection

laparoscopic intersphincteric resection .

Arm 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.

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: Trocar Placement and Exposure Rectosigmoid Mobilization and Control of Inferior Mesenteric Vessels Taking Down the Splenic Flexure rectal dissection till the levator ani muscle and resection of thye lateral ligaments then the peranal phase as in the laparotomy approach.

Outcomes

Primary Outcome Measures

Early Complications number

Secondary Outcome Measures

Duration of the intervention
Duration of surgery
Amount of blood loss and rate of blood transfusion
Amount of blood loss and blood transfusion through the operation
conversion rate for open ISR
The onset of intestinal motility.
the onset of the intestinal motility guided by (the onset of borborygmus and its sequence, time to give off flatus, time to intake liquid and solid food)
Pain score
Recording of the needed analgesia guided by pain score
Postoperative hospital stay
Outcome observers will assess the hospital stay days after both procedures
30 days follow up for re-operation in the postoperative period
readmission within 30 days after patient discharge
Late complications
Local recurrence within 2 years
The patients will be observed after the operation for 2 years for local pelvic recurrence
Distant metastasis within 2 years
Distant metastasis after the opertaion for 2 years
Clinical functional outcome
Investigators will assess the continence using Per Anal Scoring System (PASS) from 0 to 4

Full Information

First Posted
April 4, 2013
Last Updated
May 3, 2020
Sponsor
Osama Mohammad Ali ElDamshety
Collaborators
Mansoura University, Marche Polytechnic university, Ancona, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01836926
Brief Title
TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy.
Acronym
TaTME
Official Title
Transanal Minimally Invasive TME (TaTME) Versus Open Intersphincteric Resection and Total Mesorectal Excision of Stage II/III Ultralow Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Osama Mohammad Ali ElDamshety
Collaborators
Mansoura University, Marche Polytechnic university, Ancona, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
During the period between April 2013 and July 2019, a non-randomized controlled study was performed at two tertiary centers; Oncology Centre of Mansoura University and Policlinico Umberto Primo surgery department of SAPIENZA university of Rome after referral from the clinical oncology and nuclear medicine department. After diagnosis of ultralow rectal cancer, a written informed consent was obtained from patients after full explanation of the procedure, the likely outcome and the potential complications that may occur. Digital rectal examination was conducted to assess the distance of lower tumor margin from the anal verge and the anal tone. Anesthetic fitness and tumour markers (CEA) were assessed. Pelvis MRI and/or endorectal ultrasound (EUS), abdomen and chest CT scan and colonoscopy with biopsy were done for all cases. Re-evaluation after neoadjuvant chemo-radiotherapy by MRI and EUS. Inclusion criteria included a very low rectal cancer below 5 cm from the anal verge with normally continent and tumor-free external anal sphincter. Neoadjuvant treatment was given to all patients with T3 or node positive tumors. Exclusion criteria were T4, metastatic tumors and fecal incontinence. Fifty patients were excluded from the study (Fig.1). One hundred and ten patients with ultralow rectal adenocarcinoma, with matched age and sex (table 1), were non-randomly classified into two equal groups: the control group included 55 patents that underwent sphincter sparing by open ISR with TME (O-ISR Group) and the 2nd group included 55 patents that underwent Transanal minimally invasive ISR with TME (TAMIS Group). Surgical technique: In open ISR, the inferior mesenteric vessels were highly ligated. After full mobilization of the left colon and splenic flexure was done, the plane for TME was followed down in the pelvis superficial to the hypogastric fascia as low as possible to enter into the posterior intersphincteric plane. A non-endoscopic perineal phase was then initiated using an anal lone-star retractor to expose the anal canal. Both the mucosa and the muscular layer were incised 1cm below the tumor margin to transect the internal anal sphincter (IAS) and then closed by purse string sutures. The dissection continued between IAS and the external anal sphincter (EAS) starting posteriorly then laterally, where EAS is easier to identify, then anteriorly where the plane presented more adhesions with the urethra in male or vagina in female till reaching the abdominal dissection. Proximal division of the specimen started just below the site of inferior mesenteric vessels ligation and continued till division of the marginal artery at the site of the required anastomosis. The Specimen extraction and division was done extra-anal. A defunctioning ileostomy was done in all cases. In TAMIS-TME, using a lone star retractor, the 1st step was to divide and close the anal canal by purse-string suturing to enter the intersphincteric plane. Using TEo platform (Karl Storz, Tuttilingen, Germany) (fig. 2) with a 4 cm size operating proctoscope diameter, Transanal endoscopic dissection was initiated and continued in the intersphincteric plane starting posteriorly then laterally. Partial or high ISR started at the dentate line to remove the upper half of IAS for ultralow tumors at 3 to 4.5 from anal verge. Total or low ISR started 1 cm below the dentate line, removing the whole of IAS for tumours below 3 cm from the anal verge. The endoscopic dissection continued in the same sequence as the control group along the levator ani. Then continue posteriorly till reaching as much as possible, then dissection continued laterally and anteriorly to reach the peritoneal reflection. Then, the laparoscopic phase was initiated to ligate the inferior mesenteric vessels and mobilize the splenic flexure and left colon. The peritoneal reflections were then divided to connect to the transanal part. The specimen was then extracted transanally and the Colo-anal anastomosis was done in two layers. A defunctioning ileostomy was done in all cases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open intersphincteric resection
Arm Type
Active Comparator
Arm 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.
Arm Title
laparoscopic intersphincteric resection .
Arm Type
Active Comparator
Arm 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: Trocar Placement and Exposure Rectosigmoid Mobilization and Control of Inferior Mesenteric Vessels Taking Down the Splenic Flexure rectal dissection till the levator ani muscle and resection of thye lateral ligaments then the peranal phase as in the laparotomy approach.
Intervention Type
Procedure
Intervention Name(s)
Open intersphincteric resection
Other Intervention Name(s)
sphincter preserving procedures in low rectal cancer, very low rectal cancer resection, interspincteric resection
Intervention Description
laparotomy arm: surgical Instruments for open approach operation: Abdominal anterior resection combined with peranal intersphincteric resection of the rectum Abdominal step a high ligation of the inferior mesenteric artery is performed together with a full mobilization of the left colon. A circular incision of the anal canal is performed 1 cm below the tumour. Both the mucosa and the muscular layer are incised to transect the internal anal sphincter. A coloanal anastomosis, transverse coloplasty or colonic J-pouch and a diverting loop ileostomy are associated with the hand-sewn coloanal anastomosis. laparoscopic approach group: instruments used: laparoscopic instruments mentioned at the arm description intervention: laparoscopic mobilization of the rectum and colon combined with the peranal intersphincteric resection as in the laparotomy approach
Intervention Type
Device
Intervention Name(s)
transanal minimally invasive intersphincteric resection
Other Intervention Name(s)
laparoscopic low anterior resection combined with trans-anal endoscopic intersphincteric resection, lTAMIS
Intervention Description
minimally invasive approach group: instruments used: laparoscopic instruments mentioned at the arm description instruments: laparoscopic instruments mentioned in the laparoscopic rectal resection arm intervention: laparoscopic mobilization of the rectum and colon combined with the peranal intersphincteric resection as in the laparotomy approach
Primary Outcome Measure Information:
Title
Early Complications number
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Duration of the intervention
Description
Duration of surgery
Time Frame
1 day
Title
Amount of blood loss and rate of blood transfusion
Description
Amount of blood loss and blood transfusion through the operation
Time Frame
1 Day
Title
conversion rate for open ISR
Time Frame
1 day
Title
The onset of intestinal motility.
Description
the onset of the intestinal motility guided by (the onset of borborygmus and its sequence, time to give off flatus, time to intake liquid and solid food)
Time Frame
2 weeks
Title
Pain score
Description
Recording of the needed analgesia guided by pain score
Time Frame
the first two weeks in the postoperative period
Title
Postoperative hospital stay
Description
Outcome observers will assess the hospital stay days after both procedures
Time Frame
30 Days
Title
30 days follow up for re-operation in the postoperative period
Description
readmission within 30 days after patient discharge
Time Frame
1 month
Title
Late complications
Time Frame
2 years
Title
Local recurrence within 2 years
Description
The patients will be observed after the operation for 2 years for local pelvic recurrence
Time Frame
2 years
Title
Distant metastasis within 2 years
Description
Distant metastasis after the opertaion for 2 years
Time Frame
2 years
Title
Clinical functional outcome
Description
Investigators will assess the continence using Per Anal Scoring System (PASS) from 0 to 4
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mansoura oncology centre
City
Mansoura
State/Province
El Dakahlia
Country
Egypt
Facility Name
Mansoura university oncology centre
City
Mansoura
State/Province
El-dakahlia
Country
Egypt

12. IPD Sharing Statement

Citations:
Citation
[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
Results Reference
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TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy.

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