Philip Mitta, (2014) Randomised trial to assess the efficacy of pelvic drainage in preventing pelvic collection after elective rectal resection for cancer. Masters thesis, Christian Medical College, Vellore.
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Abstract
INTRODUCTION: Rectal cancer is the third most commonly diagnosed cancer occurring in both males and females globally. In India, the incidence of rectal cancer among males is higher than females, which is different from the rest of the world. Increasing incidence among younger males in India has been seen as a trend. Low socioeconomic status has been seen to be associated with the incidence of rectal cancer both globally and in India. Though the management of rectal cancer is multimodal, adequate surgical resection is the mainstay of treatment and is considered the primary treatment modality. Rectal resection remains a morbid operation, one of the most troublesome complications being pelvic collection. Pelvic drainage by means of closed tubular drainage has been practised routinely with the objective of reducing the post operative morbidity. This study aims to observe the role of closed tube pelvic drainage in the post operative outcome following rectal resection. Although the ineffectiveness of such an intervention in reducing postoperative morbidity has been established in patients undergoing small intestinal and colonic resections, there is no conclusive data in patients undergoing rectal resection. In fact the effectiveness of such an intervention for rectal resection has been questioned. OBJECTIVES: 1. To detect the presence of pelvic collection by ultrasonographic imaging of the pelvis on the 5th post operative day and measure its volume if present. 2. To assess the morbidity in terms of deviation in the normal post operative course 3. To record the number of days of hospital stay according to ‘fit for discharge’ criteria. 4. To document the occurrence of urinary tract infection (UTI) during the post operative period (30 days following surgery). METHODS: The study was a randomized controlled trial which included all patients undergoing elective rectal resection under General Surgery Unit 2. The intervention was absence of pelvic drainage and this was compared against the comparator which was closed pelvic drainage. The exclusion criteria were: 1. Patients operated on an emergency basis. 2. Patients with disseminated disease where surgery is a palliative procedure. 3. Patients with compromised immunity (on steroids, immunosupression, post transplant patients). 4. Patients with intraoperative complications for which drainage is inevitable (spillage). The method used for randomisation was a block randomisation with concealment in sealed envolopes. The sample size was calculated by a two proportion methos with a power of 80% and an alpha error of 5%. Statistical analysis was performed by means of chi square test and independent sample T test. RESULTS: Although the study was not carried on till the complete sample size was reached, the results were all consistent and showed trends in the same direction. However, statistically significant conclusions cannot be drawn from the analysis of the results. The duration of the study and the time constraint is one of the major limitation of this study. Apart from this, sensitivity of a pelvic ultrasonogram, observer bias and the inability to perform blinding are the other limitations. The increased incidence of rectal cancer among younger males has stood out in this study which is in contrast with studies from the western population. The use of pelvic drainage has not shown to drastically contribute towards reducing post operative morbidity in terms of decreased pelvic collections or reduced hospital stays. Infact, the absence of a pelvic drain has shown a trend towards reduced incidence of pelvic collection and reduced hospital stay. However, these results are not statistically significant. CONCLUSIONS: The aim of conducting this study was to establish a definitive association between the routine use of closed tube drainage of the pelvis in patients undergoing resection for rectal cancer. The paucity of data in this area and the equivocal results of existing studies further warranted the need for this study. Although the study was not carried on till the complete sample size was reached, the results were all consistent and showed trends in the same direction. However, statistically significant conclusions cannot be drawn from the analysis of the results. The duration of the study and the time constraint is one of the major limitation of this study. Apart from this, sensitivity of a pelvic ultrasonogram, observer bias and the inability to perform blinding are the other limitations. The increased incidence of rectal cancer among younger males has stood out in this study which is in contrast with studies from the western population. The use of pelvic drainage has not shown to drastically contribute towards reducing post operative morbidity in terms of decreased pelvic collections or reduced hospital stays. Infact, the absence of a pelvic drain has shown a trend towards reduced incidence of pelvic collection and reduced hospital stay. However, these results are not statistically significant. The other factor that contributed to the outcome of these patients was neoadjuvant therapy in the form of long course chemoradiation. The lack of unequivocal evidence in the benefit of routine pelvic drainage has shown that it is a questionable intervention.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | pelvic drainage, preventing pelvic collection, elective rectal resection, cancer. |
| Subjects: | MEDICAL > General Surgery |
| Depositing User: | Devi S |
| Date Deposited: | 21 Mar 2020 17:07 |
| Last Modified: | 21 Mar 2020 17:07 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/12403 |
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