Safety and radiosensitizing efficacy of sanazole (AK 2123) in oropharyngeal cancers: randomized controlled double blind clinical trial.

Oropharynx is an important site of cancer in India. Global comparison indicates higher incidences in India. Radiotherapy remains an important treatment modality. Efforts to improve loco-regional treatment and prolong survival are areas of focus. Radiosensitizers in hypoxic tumors have shown promise. AIM: To study the safety and radiosensitizing efficacy of sanazole in oropharyngeal squamous cell carcinoma (stage T2-4, N0-3, M0) as phase-II double blind controlled trial in patients treated with conventional radiotherapy. SETTINGS AND DESIGN: Single institutional, randomized, double-blind, placebo-controlled trial. MATERIALS AND METHODS: Group 1 (control; n = 23) received normal saline infusion, group 2 (test; n = 23) received sanazole biweekly 1.25 g intravenous infusion 15 minutes before radiotherapy. Surrogate end points of efficacy were tumor and nodal size; safety parameters were mucositis, salivary and skin reactions, dysphagia, vomiting, dysgeusia and neurological deficit. Investigators blinded to the trial evaluated patients, weekly during treatment for six weeks and thereafter monthly for three months. STATISTICAL METHODS: Non-parametric, Friedman's, Chi square, Mann-Whitney U tests. RESULTS: In the test, 15 (65%) patients had complete response, five (22%) partial/no response, two (9%) died, one (4%) lost to follow up. In the control, five (22%) patients had complete response, 16 (70%) partial/no response, one (4%) died, one (4%) lost to follow up. Short-term loco-regional response was better in the test (DF = 3, 95% Confidence Interval 0.418, 0.452, P = 0.0048). In the test group significant vomiting and one case of grade 3 neurological deficit was observed. CONCLUSION: The study validates the usefulness of sanazole for initial loco-regional control in oropharyngeal cancers.

Incontinentia pigmenti.

Incontinentia pigmenti or Bloch-Sulzberger syndrome, is a rare X linked dominant disorder with characteristic skin, hair, eye, dental and neurological abnormalities commonly affecting females. This article reports the clinical features and management of a 11 year old girl diagnosed with Incontinentia pigmenti.

Pattern of nontyphoid ileal perforation over three decades in Pondicherry.

Two hundred and twelve cases of ileal perforation due to different causes (excluding typhoid) were treated in 3 phases in the Department of Surgery, JIPMER Hospital, Pondicherry, during the periods 1966-78 (phase I), 1981-88 (phase II) and 1990-1998 (Phase III). Forty per cent of the patients were in the second and third decades of life. Male-to-female ratio was 2.2:1. The majority of the perforations (52.8%) were due to non-specific causes. Trauma (19.3%) and mechanical factors (12.7%) were the other principal aetiologies. Pain abdomen (92.3%), constipation (63.6%) and fever (44.3%) were the principal presenting features. Abdominal guarding and rigidity (89%) were the main physical signs. Pneumoperitoneum was present in 66.8% of cases on plain X-ray abdomen. Widal and blood culture for Salmonella typhi were negative in all. Laparotomy was done in most of the cases after adequate resuscitation. Simple closure of the perforation, wedge resection and resection anastomosis were the different procedures of management. Histology of the margin of perforation/excised gut gave added evidence of a non-typhoid etiology. Broad-spectrum antibiotics in different combinations with metronidazole were administered postoperatively. Mortality was 28.2% in Phase I, and 9.4% and 11.9% in phases II and III respectively. The lag period (advent of symptoms and hospitalization) showed definite relationship with mortality and morbidity. Wound infection, wound dehiscence, enterocutaneous fistula and septicaemia were the principal postoperative complications.

Factors contributing to releak after surgical closure of perforated duodenal ulcer by Graham's Patch.

BACKGROUND: Perforated duodenal ulcer is one of the common surgical emergencies. Releak after duodenal ulcer perforation closure is an important cause of mortality. This study was planned to analyse risk factors if any, which could predict releak following duodenal ulcer perforation closure and to ascertain the contribution of releak towards ultimate outcome. METHODS: A prospective study was undertaken between September 1997 and August 1999 including all patients undergoing surgery for perforated duodenal ulcer. All patients (119) underwent a Graham's patch closure and were put on parenteral H2 antagonists and antibiotics postoperatively. Patients with releak were included in case group (9), and those without releak were included in control group (110). Factors considered for comparison among the two groups were age, pulse rate, systolic blood pressure at presentation, anthropometeric parameters, haemoglobin, serum total protein/albumin, total lymphocyte count and operative findings including size of perforation, evidence of chronicity of ulcer, quantity and nature of peritoneal fluid. RESULTS: Age greater than 60 years (p-0.0470, CI-0.76-31.54), pulse rate greater than 110/minute (p-0.0217, CI-1.04-34.48), systolic blood pressure less than 90 mm Hg (p-0.0016, CI-2.04-71.9), haemoglobin level less than 10 g/dl (p-0.0009, CI-2.25-135.02), serum albumin less than 2.5 grams/dl (p-0.0145, CI-1.21-38.31), total lymphocyte count less than 1800 cells/mm-3 (p-0.0003, CI-8.9-42.2), size of perforation greater than 5 mm (p-0.0011, CI-1.09-36.13) were identified as risk factors for releak. Serum albumin, hemoglobin and size of perforation were independent risk factors for prediction of releak on multivariate analysis. The anthropometric parameters namely mean triceps skin fold thickness, mean mid arm circumference and mean body mass index were all significantly less in cases as compared to controls. Releak was found to be a significant cause of death in patients with perforated duodenal ulcer. A total of 8 patients died in both the groups. The mortality rate in the releak group was 55.6% (5 out of 9 patients) compared to 2.7% (3 out of 110 patients) in the control group [p-0.0001]. CONCLUSION: Releak was a significant factor influencing mortality rate after omental patch closure of perforated duodenal ulcer.

Changing trends in outcome of typhoid ileal perforations over three decades in Pondicherry.

Two hundred and forty eight cases of proved typhoid ileal perforation were admitted and treated in three phases in the department of surgery during 1966-1998. Of these, 71% patients belonged to second and third decades of life. Male female ratio was 4:1. Abdominal pain (100%) fever (95%) and constipation (87%) were the main presenting symptoms. Abdominal guarding and rigidity (84%) were the principal physical signs. Plain radiograph of abdomen showed evidence of pneumoperitoneum in 57% of cases. The Widal test was positive for S. typhi in 74% of cases. Blood and bone marrow culture were positive for S. typhi in 9% and 30% respectively. Histology of the excised edges of perforation confirmed typhoid pathology in 62% of specimens. Many of the patients were treated conservatively in the first phase. In phase two and three vigorous resuscitation and early surgery was resorted to. Simple closure in two layers and wedge resection were the treatment of choice in most of the cases. Bypass, ileostomy and resection were done on few occasions. Chloramphenicol was the only drug used in the first phase. Other broad spectrum antibiotics were added to chloramphenicol with metranidazole in the second phase. Ciprofloxacin and metronidazole were the drugs of choice in the third phase. The mortality rate showed a dramatic improvement from 47.2% (first phase) to 17.7% (second phase) and as low as 7% in the last phase. The lag period (advent of symptoms to time of admission to hospital) showed definite correlation with mortality. Septicemia, wound infection, dehiscence, enterocutaneous fistula were the principal postoperative complications.

Inguinal herniorrhaphy under local anaesthesia and spinal anaesthesia--a comparative study.

A prospective study was conducted at JIPMER, Pondicherry from September 1993 to June 1995. Fifty cases of inguinal herniorrhaphy were done under local anaesthesia (LA) and 60 cases under spinal anaesthesia (SA). The aim was to assess the safety and efficacy of inguinal herniorrhaphy under LA. The parameters studied were: (i) Efficacy of the anaesthesia, (ii) safety and postoperative course, and (iii) patient satisfaction. The LA group patients had better postoperative analgesia and earlier return to ambulation. They did not suffer the postspinal complications of headache and urinary retention. However, intra-operative discomfort was significantly more in this group compared to the SA group.

Transection of common bile duct following blunt injury to abdomen.

Isolated complete transection of the common bile duct due to blunt abdominal trauma is rare. We report such a case following an assault.

Spontaneous appendicocutaneous fistula.

Spontaneous appendicocutaneous fistula is a rare complication of appendicitis. We report a case of appendicular carcinoid who presented with appendicocutaneous fistula.

Gastric wall necrosis in an HIV-positive patient.

Perforation of the gastrointestinal tract is rare in HIV infection and occurs most often in the colon and small intestine. Gastric perforation in HIV-positive patients has not been reported so far. We report an HIV-positive patient who developed gastric perforation.