Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer

Serra‐Aracil, Xavier; Zarate, Alba; Mora, Laura; Serra, S.; Pallisera, Anna; Bonfill, Joan; Bargalló, Josep; Pando, Ana Pajuelo; Delgado, Salvadora; Balleteros, E.; Pericay, C.

doi:10.1007/s00384-018-2996-8

Cited by 3 publications

(3 citation statements)

References 31 publications

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“…Studies comparing transanal TME to other approaches of rectal cancer treatment need to be conducted to better assess the potential benefit in cancerspecific outcomes and patients' overall wellbeing. Two future randomized studies may help clarify these questions [55,56] .…”

Section: Discussionmentioning

confidence: 99%

“…Although the primary endpoint will be the circumferential resection margin, the secondary endpoints will include disease-free survival, overall survival, and quality of life. Serra-Aracil et al [56] published a protocol to study a combined TaTME combined with laparoscopy to evaluate if there would be a lower conversion rate than laparoscopic low anterior resection, and potentially improve patient recovery and overall morbidity, and quality of life measures. Quality of life measures will be examined preoperatively and 6 months after the closure of protective ileostomy using the EORTC QLQ-C30, QLQ-CR29, and LARS score.…”

Section: Tatmementioning

confidence: 99%

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Quality of life after minimally invasive surgery for rectal cancer

Chen¹,

Ayscue²,

Bayasi³

et al. 2018

MIS

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of life after minimally invasive surgery for rectal cancer. Mini-invasive Surg 2018;2:42. http://dx. AbstractTraditional open surgical technique for rectal cancer is associated with significant morbidity and impact on quality of life. Multiple structures are at risk during total mesorectal excision, which may have profound impact on sexual function, and urinary and fecal continence. In addition, having a temporary or permanent ostomy can have a significant effect on overall well-being. Patients have reported post-operative problems such as chronic wounds, poor body image, inhibited work and social function. Minimally invasive surgery (MIS) is an evolving component of colon and rectal cancer treatment that may have benefits over open surgery. The increasing role of laparoscopy for colon and rectal cancer has been associated with decreased morbidity, improved pain control, and reduced length of stay. However, laparoscopic surgery in rectal cancer remains technically difficult due to the inherent limitations of operating in the pelvis. Robotic surgery is a newer method for treating rectal cancer developed to overcome these limitations. Transanal endoscopic microsurgery and transanal MIS are techniques to achieve local excision, avoiding proctectomy in select patients, potentially improving functional outcomes. Transanal total mesorectal excision is an even newer technique to facilitate dissection of low rectal cancers. Controversy remains about equivalence in oncologic outcomes when these MIS approaches are used for rectal cancer. Even more unclear is the effect of MIS approaches on quality of life and how they compare to open surgery. This review discusses the most current evidence on the impact of various MIS techniques on quality of life after rectal cancer surgery. Keywords:Quality of life, rectal cancer, minimally invasive surgery, laparoscopic, robotic, transanal endoscopic microsurgery, transanal minimally invasive surgery, transanal total mesorectal excision DECLARATIONS Authors' contributionsConception and design of the work, acquisition, analysis, interpretation of data, drafting and revising the work: Chen JH, Bello BL Conception and design of the work, revising the work:

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Section: Discussionmentioning

confidence: 99%

Section: Tatmementioning

confidence: 99%

Quality of life after minimally invasive surgery for rectal cancer

Chen¹,

Ayscue²,

Bayasi³

et al. 2018

MIS

View full text Add to dashboard Cite

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“…The exclusion criteria are open surgery or conversion to open surgery (defined as any intervention that requires removal of laparoscopic material and conversion to traditional open surgery [9]); administration of epidural anaesthesia or ASA IV; preoperative diagnosis of urinary tract infections (more than three episodes/year documented by urine culture, or two urinary tract infections in the last 6 months); moderate–severe prostate clinical symptoms (IPSS > 20); in men, the presence of positive urine culture in preoperative tests; in women, clinical symptoms of urine infection with positive urine culture. Previous history of AUR, the presence of a permanent bladder or ureteral catheter and intermittent self‐catheterization will also be grounds for exclusion.…”

Section: Methodsmentioning

confidence: 99%

Multicentre, prospective, randomized control non‐inferiority trial of bladder catheter management in colon surgery

Serra‐Aracil,

Hidalgo,

Dominguez

et al. 2023

Colorectal Disease

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Aim Perioperative bladder catheterization is a controversial issue. Most current recommendations are based on data from open surgery extrapolated to enhanced recovery after surgery or fast‐track programmes ranging between 24 and 48 h. The aim of this study is to provide a rationale for reducing catheterization time while at the same time avoiding acute urine retention (AUR), in patients undergoing scheduled laparoscopic colon surgery. Method This is a multicentre, prospective, controlled, randomized non‐inferiority study of bladder catheter management in patients undergoing scheduled laparoscopic colon surgery, randomized into two groups: experimental (with catheter removal immediately after surgery) and control (with catheter removal 24 h post‐surgery). The main outcome will be the development of AUR, and secondary outcomes the development of urinary infection within the first 30 days and hospital stay. Demographic, surgical and pathological variables will also be evaluated, especially the development of adverse effects assessed according to the Clavien scale and the Comprehensive Complication Index. Following the literature, we assume an incidence of AUR of 11% and a margin of non‐inferiority (delta) of 8% and estimate that a sample size of 208 patients per group will be required (with an estimated 10% of losses per group). Conclusions In this study we try to demonstrate that the bladder catheter can be removed immediately after scheduled laparoscopic colon surgery, without increasing acute urine retention. This measure would offers the benefits of earlier mobilization and reduces catheter‐related morbidity.

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