ABSTRACT
OBJECTIVE: To compare mechanical bowel preparation (MBP) using oral magnesium citrate with sodium phosphate enema to sodium phosphate (NaP) enema alone during minimally invasive pelvic reconstructive surgery. METHODS: We conducted a single-blind, randomized controlled trial of MBP versus NaP in women undergoing minimally invasive pelvic reconstructive surgery. The primary outcome was intraoperative quality of the surgical field. Secondary outcomes included surgeon assessment of bowel handling and patient-reported tolerability symptoms. RESULTS: One hundred fifty-three participants were enrolled; 148 completed the study (71 MBP and 77 NaP). Patient demographics, clinical and intraoperative characteristics were similar. Completion of assigned bowel preparation was similar between MBP (97.2%) and NaP (97.4%). The MBP group found the preparation more difficult (P<0.01) and reported more overall discomfort and negative preoperative side effects (all P≤0.01). Quality of surgical field at initial port placement was excellent/good in 80.0% of the MBP group compared with 62.3% in the NaP group (P=0.02). This difference was not maintained by the conclusion of surgery (P=0.18). Similar results were seen in the intent-to-treat population. Surgeons accurately guessed preparation 65.7% of the time for MBP versus 41.6% for NaP (P=0.36). At 2 weeks postoperatively, both reported a median time for return of bowel function of 3.0 (2.0-4.0) days. CONCLUSIONS: Mechanical bowel preparation with oral magnesium citrate before minimally invasive pelvic reconstructive surgery offered initial improvement in the quality of surgical field, but this benefit was not sustained. It was associated with an increase in patient discomfort preoperatively, but did not seem to impact postoperative return of bowel function. LEVEL OF EVIDENCE: I.
Subject(s)
Cathartics/administration & dosage , Citric Acid/administration & dosage , Enema/methods , Organometallic Compounds/administration & dosage , Pelvic Floor/surgery , Phosphates/administration & dosage , Cathartics/adverse effects , Citric Acid/adverse effects , Female , Humans , Laparoscopy , Middle Aged , Organometallic Compounds/adverse effects , Pelvic Organ Prolapse/surgery , Postoperative Period , Preoperative Care/methods , Plastic Surgery Procedures/methods , Robotic Surgical Procedures , Single-Blind MethodABSTRACT
OBJECTIVES: This study aimed to compare TVT-Secur (TVT-S) and TVT-Obturator (TVT-O) suburethral slings for treatment of stress urinary incontinence (SUI). METHODS: This was a single-center, nonblinded, randomized trial of women with SUI who were randomized to TVT-S or TVT-O from May 2007 to April 2009. The primary outcome, SUI on cough stress test (CST), and quality-of-life and symptom questionnaires (Pelvic Floor Distress Inventory [PFDI-20] and Pelvic Floor Impact Questionnaire [PFIQ-7]) were assessed at 12 weeks and 1 year. RESULTS: Forty-three women were randomized to TVT-S and 44 to TVT-O. There were no differences in median baseline PFDI-20 and PFIQ-7. Twenty-two (52.4%) of 42 participants randomized to TVT-S had a positive CST result at evaluation after 12 weeks or 1 year, whereas 4 (9.1%) of the 44 in the TVT-O group had a positive CST result. The intent-to-treat analysis showed that the risk of a positive CST result was 6 times higher after TVT-S than TVT-O (risk ratio, 6.0; 95% confidence interval [CI], 2.3-16.0). Among women not lost to follow-up, the risk ratio for a positive CST result after TVT-S compared with TVT-O was 17.9 (95% CI, 2.5-128.0) at 12 weeks and 3.5 (95% CI, 1.1-11.0) at 1 year. Both TVT-S and TVT-O resulted in improved quality of life and symptoms at 12 weeks. There was no difference between the groups for PFDI-20 (P = 0.40) or PFIQ-7 (P = 0.43). A similar pattern was seen at 1 year (P = 0.85 and P = 0.36). CONCLUSIONS: The TVT-S seems to have a higher risk of positive postoperative CST result; however, the procedures result in similar improvements in quality of life and symptoms.
