TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy.

Rectal Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836926
• Other study ID #: Mansoura oncology centre
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: July 2019

Study information

• Verified date: May 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Open intersphincteric resection
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

Device:
• transanal minimally invasive intersphincteric resection
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

Locations

Country	Name	City	State
Egypt	Mansoura oncology centre	Mansoura	El Dakahlia
Egypt	Mansoura university oncology centre	Mansoura	El-dakahlia

Sponsors (3)

Lead Sponsor	Collaborator
Osama Mohammad Ali ElDamshety	Mansoura University, Egypt, Marche Polytechnic university, Ancona, Italy

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

[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 can

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Complications number		2 years
Secondary	Duration of the intervention	Duration of surgery	1 day
Secondary	Amount of blood loss and rate of blood transfusion	Amount of blood loss and blood transfusion through the operation	1 Day
Secondary	conversion rate for open ISR		1 day
Secondary	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)	2 weeks
Secondary	Pain score	Recording of the needed analgesia guided by pain score	the first two weeks in the postoperative period
Secondary	Postoperative hospital stay	Outcome observers will assess the hospital stay days after both procedures	30 Days
Secondary	30 days follow up for re-operation in the postoperative period	readmission within 30 days after patient discharge	1 month
Secondary	Late complications		2 years
Secondary	Local recurrence within 2 years	The patients will be observed after the operation for 2 years for local pelvic recurrence	2 years
Secondary	Distant metastasis within 2 years	Distant metastasis after the opertaion for 2 years	2 years
Secondary	Clinical functional outcome	Investigators will assess the continence using Per Anal Scoring System (PASS) from 0 to 4	1 year