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Early takedown of a defunctioning ileostomy, is there a downside? – a prospective analysis from Rural Bengal

A “defunctioning” ileostomy is often used as a temporary method of faecal diversion in surgeries of the colon that include a distal colonic anastomosis. Such a stoma prevents anastomotic leak and peritonitis from the index surgery. A few surgeons perform proximal defunctioning colostomies but a defunctioning Ileostomy has as clear set of advantages, there is less chances of stoma prolapse and it is easy to restore without compromising the vascular arcade. Although there are minor differences between a defunctioning and loop ileostomy, for the sake of simplicity they are considered synonymous in this study. The timing of reversal of these defunctioning stomas have been a matter of debate. The Western world has seen an increased number of reversals within a week of the index operation, since the pilot study conducted by Bakx et al in 2002 showed the feasibility of reversal by 11 days without any significant morbidity. However, the situation seems to be more dubious, with skepticism to deviate from the traditional teaching, of performing the stoma takedown after the “window of doom” (from 10 days to 6 weeks) in a developing country, among the rural population where there is a lack of research and an expert consensus.


INTRODUCTION
A "defunctioning" ileostomy is often used as a temporary method of faecal diversion in surgeries of the colon that include a distal colonic anastomosis. Such a stoma prevents anastomotic leak and peritonitis from the index surgery. A few surgeons perform proximal defunctioning colostomies but a defunctioning Ileostomy has as clear set of advantages, there is less chances of stoma prolapse and it is easy to restore without compromising the vascular arcade. 1 Although there are minor differences between a defunctioning and loop ileostomy, for the sake of simplicity they are considered synonymous in this study. The timing of reversal of these defunctioning stomas have been a matter of debate. The Western world has seen an increased number of reversals within a week of the index operation, since the pilot study conducted by Bakx et al in 2002 showed the feasibility of reversal by 11 days without any significant morbidity. 2 However, the situation seems to be more dubious, with skepticism to deviate from the traditional teaching, of performing the stoma takedown after the "window of doom" (from 10 days to 6 weeks) in a developing country, among the rural population where there is a lack of research and an expert consensus.
index surgery, to a more traditionally accepted duration of [8][9][10][11][12] weeks. This study is set amidst a rural Indian population, in our teaching institution in Bengal.

METHODS
This prospective longitudinal comparative study was undertaken in the Department of General Surgery of Bankura Sammilani Medical College and Hospital over a duration of 18 months from February 2018 to July 2019, after obtaining an Ethical clearance from the Institutional Ethical Committee, according to the ethical standards for conducting experiments on human subjects and in accordance to the Declaration of Helsinki 1975, revised in 2013.

Sample size
The sample size was calculated with a total of 60 patients with 30 patients in each group.

Subject allocation and assignment into groups
Of the 246 patients with Ileostomies, 96 patients had loop or defunctioning Ileostomies. Among these patients those satisfying our inclusion criteria were included in the study while those who fell in the exclusion criteria were rejected. Using the above-mentioned technique of sampling a total of 60 patients were included with 30 in each arm of the study. The participants were included only after obtaining a written consent to participate in the study. Patients were randomly assigned into the Early and Delayed group using simple random number tables. The socio-demographic, comorbidities and details of the index surgery and stoma related complications were documented as descriptive data.
The Early subset of the study arm underwent a takedown by 2 weeks and the delayed subset underwent a takedown by 8-12 weeks. The post-operative course was observed and the results in between the two groups were compared. The primary endpoint of this study was the end of a successful follow up of the patients six months after the stoma reversal. (Figure 1).

Surgical technique of ileostomy takedown
The prerequisites to the Ileostomy takedown constituted blood investigations, electrolytes. A distal loop-o-gram was performed prior to takedown to check the patency of the distal anastomosis and the presence of any leaks. All out patients were given mechanical bowel preparation prior to takedown ( Figure 1).  The surgical procedure of takedown commenced was carried out by the consultant surgeon, and the primary researcher observed the procedure. A circumferential incision was made around the Ileostomy after taking muco-cutaneous stay sutures. After deepening the incision to the rectus sheath, adhesions around the bowel were gently dissected, while simultaneously mobilizing the bowel. A certain number of cases, that posed significant difficulty to mobilize the bowel with a circumferential incision, and those which suffered an inadvertent enterotomy or haemorrhage from the mesentery were converted to a formal Laparotomy. The margins of the stoma were refashioned by truncating the proximal end of the Ileostomy spigot and a hand sewn anastomosis was performed using 3-0 Silk sutures, (SILKUS®, Lotus) on the fresh margins of the bowel using a single layer extramucosal technique.

Data collection
Pre-designed questionnaires were used to document the preoperative, perioperative and post-operative data and the results were tabulated in Microsoft Excel 2016.

Statistical analysis
The data was analyzed by SPSS (version 24.0; SPSS Inc., Chicago, IL, USA) and Graph Pad Prism version 5 Table 4. where, p<0.001 and was statistically significant. These has been represented in (Figure 4), which shows an increased hospitalization among the subset of patients undergoing and early closure (Figure 4).

DISCUSSION
The pilot study by Bakx et al in 2002 showed the feasibility of a less morbid defunctioning ileostomy takedown by 11 days. 2 Many surgeons, in their studies and researchers in their systematic reviews have since then evaluated an intervention that tried to cut short the stoma bearing duration for the patient. It is imperative to understand that a stoma definitely has psychological and sexual shortcomings and since these stomas would be constructed for temporary faecal diversion they would be unnecessary after they have served their purpose. 5,6 A persistent stoma may cause renal implications as stated by Gessler et al, Menegaux et al confirmed that a high output stoma demands an early closure. 7,8 However, there is no consensus regarding the actual time period for reversal of stomas. An extremely early intervention may be a bane altogether. The role of an early takedown has been best studied in patients with a distal colonic anastomosis like complicated low or ultralow anterior resections, in rectal cancer or in cases of ulcerative colitis after proctocolectomy. [9][10][11][12][13][14][15][16] They seem to be more cost effective. 17 Recent studies have shown the feasibility of laparoscopic reversal with minor complications. 18 There seems to be no difference between staplers and hand sewn anastomosis, but stapled bowel opens faster. 19 Further more educated people opt for early reversal. 20 Our institute is a high-volume tertiary care center that caters to the rural population of Bengal and hence most of our patient's harboring the disease present late, due to lack to knowledge and paucity of their caregivers to attend the hospital in definite time. This study focused on the implications and feasibility of early reversal of Ileostomies in selected groups of patients. Most of our patients come from the rural population and hence the stoma related complications are on the rise. They do not seek prompt medical attention and care for their stomas. Most of them suffer from stoma related complications, majority of them being poor peristomal skin care. Residents in training perform a high volume of Emergency surgeries hence the technical correctness of a stoma is also questionable. The morbidity with the stoma is the primary reason for undertaking an Early Closure, which is in according to Alves et al and Jordi-Galais et al. 5,6 High output stomas mandated a prompt takedown, which is consistent to the study as described by Menegaux et al .8 Hence an early takedown would be beneficial to such patients.

Mean±SD
Delayed Closure Our study has a few shortcomings. The cost analysis and evaluation of the quality of life may be the limitations of our study because, our institute provides all the necessary drugs and equipment without any charge. Majority of the patients in this study are rural, and have an erratic follow up. Although none of our patients were lost to follow up, due to their erratic nature of presentation to follow up clinics, but it proved to be difficult to maintain their data for the researchers. Furthermore, the study includes a small group of patients. A larger subset and the inclusion of data from other institutions may increase the complications further and throw light to the limitations of our study. All of our Ileostomy reversals were hand sewn, hence the merit of a stapled anastomosis was not evaluated. Wound complications may be an institutional concern. Further studies like the recent easy trial if conducted in a large scale including many institutions, in India may shed more light on different perspectives of Ileostomy reversals.

CONCLUSION
It is clear from our study that the subset of patients undergoing an Early ileostomy closure, may need a longer operative time due to intraoperative adhesions, the post-operative complications are on the higher side thus prolonging the duration of hospital stay. Since, expert consensus (level I) Indian data is lacking. Future studies on this debate may determine the fate of this technique in a rural Indian set-up.